Changes to the regulation of autologous cells and tissuesTGA Australia
Presentation provides an overview of the changes to the regulation of autologous HCT, inlcuding guidance on restrtictions to advertiisng content and the need to report advert events.
TGA presentation: Postmarket MonitoringTGA Australia
View this presentation for information on:
what postmarket monitoring is and why it is important
tools used in postmarket monitoring, including risk management plans
managing risk and adverse events
the TGA's early warning system and recall actions.
Postmarket monitoring of therapeutic goods in AustraliaTGA Australia
View this presentation for information on:
* what postmarket monitoring is and why it is important
* tools used in postmarket monitoring, including risk management plans
* managing risk and adverse events
* the TGA's early warning system and recall actions.
The regulation of biologicals in AustraliaTGA Australia
View this presentation for information on:
* what biologicals are, including classes and current uses
* the Australian biologicals framework
* new and experimental products
* clinical trials and risk management.
An introduction to the work of Australia's regulator of therapeutic goodsTGA Australia
View this presentation for information on:
* who we are, how we regulate, and why we need regulation
* the different types of therapeutic goods and the Australian Register of Therapeutic Goods
* our benefit versus risk approach to regulation
* the activities we undertake both before and after a product is released to the market
Presentation: Regulation of autologous cells and tissuesTGA Australia
This presentation provides an overview and describes the recent TGA public consultation on the exclusion of some autologous cell therapies from regulation.
TGA Presentation: TGA’s Role in Clinical Trials Regulation and AdministrationTGA Australia
The document provides an overview of TGA's role in regulating clinical trials in Australia. It discusses:
1) The CTN and CTX pathways for accessing unapproved therapeutic goods for clinical trials and the responsibilities of sponsors, HRECs, and TGA under each scheme.
2) Safety reporting requirements for clinical trials, including reporting timeframes and what must be reported.
3) Other regulatory requirements like advertising and labelling.
4) Answers to common questions about clinical trials regarding variations, completion notifications, import permits, and special requirements for trials involving medicinal cannabis.
5) An update to TGA's Clinical Trials Handbook to reflect current practices.
Changes to the regulation of autologous cells and tissuesTGA Australia
Presentation provides an overview of the changes to the regulation of autologous HCT, inlcuding guidance on restrtictions to advertiisng content and the need to report advert events.
TGA presentation: Postmarket MonitoringTGA Australia
View this presentation for information on:
what postmarket monitoring is and why it is important
tools used in postmarket monitoring, including risk management plans
managing risk and adverse events
the TGA's early warning system and recall actions.
Postmarket monitoring of therapeutic goods in AustraliaTGA Australia
View this presentation for information on:
* what postmarket monitoring is and why it is important
* tools used in postmarket monitoring, including risk management plans
* managing risk and adverse events
* the TGA's early warning system and recall actions.
The regulation of biologicals in AustraliaTGA Australia
View this presentation for information on:
* what biologicals are, including classes and current uses
* the Australian biologicals framework
* new and experimental products
* clinical trials and risk management.
An introduction to the work of Australia's regulator of therapeutic goodsTGA Australia
View this presentation for information on:
* who we are, how we regulate, and why we need regulation
* the different types of therapeutic goods and the Australian Register of Therapeutic Goods
* our benefit versus risk approach to regulation
* the activities we undertake both before and after a product is released to the market
Presentation: Regulation of autologous cells and tissuesTGA Australia
This presentation provides an overview and describes the recent TGA public consultation on the exclusion of some autologous cell therapies from regulation.
TGA Presentation: TGA’s Role in Clinical Trials Regulation and AdministrationTGA Australia
The document provides an overview of TGA's role in regulating clinical trials in Australia. It discusses:
1) The CTN and CTX pathways for accessing unapproved therapeutic goods for clinical trials and the responsibilities of sponsors, HRECs, and TGA under each scheme.
2) Safety reporting requirements for clinical trials, including reporting timeframes and what must be reported.
3) Other regulatory requirements like advertising and labelling.
4) Answers to common questions about clinical trials regarding variations, completion notifications, import permits, and special requirements for trials involving medicinal cannabis.
5) An update to TGA's Clinical Trials Handbook to reflect current practices.
The document outlines the regulation of medicines in South Africa. It discusses the key pieces of legislation, the Medicines Control Council (MCC) mandate to regulate medicines, clinical trials, and manufacturers. It also covers flexibilities in the law around access like compassionate use. Current challenges include inspection capacity and emerging areas like advanced therapies. Regulation of biosimilars follows EMA guidelines largely. Global cooperation among regulators is important for efficiency and responsiveness.
Presentation: The challenges of regulating direct to consumer digital medical...TGA Australia
The document discusses the challenges of regulating direct-to-consumer digital medical devices. It describes what digital medical devices are, including connected devices, telehealth, apps, and wearables. The Therapeutic Goods Administration (TGA) regulates medical devices in Australia to ensure they are safe and effective. However, digital devices pose new challenges as many are software-based and consumers may not understand their intended medical purpose. The TGA must determine how to appropriately apply existing regulations to these new technologies.
An introduction to the work of Australia’s regulator of therapeutic goodsTGA Australia
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia to protect public health and safety. The TGA evaluates medicines, medical devices, and other therapeutic goods before and after market approval based on quality, safety, efficacy, and risk level. It maintains a register of approved products and monitors the market, responding to issues that arise. In the future, regulation may be conducted jointly with New Zealand under a single agency.
Better medicine labels: New requirements under TGOs 91 and 92TGA Australia
The document discusses new requirements for medicine labels under Therapeutic Goods Orders 91 and 92. Key points include:
1) The orders aim to improve safety and quality use of medicines by ensuring important health information is consistently located and not obscured on labels.
2) They require active ingredients to be prominently displayed, introduce a transition period until 2020 when TGO 69 is replaced, and establish two orders - one for prescription medicines and one for non-prescription.
3) Changes include larger active ingredient text, mandatory space for pharmacy labels on prescription medicines, and listing critical health information for non-prescription medicines.
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
Manufacturing Investigational Medicinal Products - Legislative and GMP requir...TGA Australia
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
Australia has strict regulations for pharmaceuticals and medical devices overseen by the Therapeutic Goods Administration (TGA). Medicines and devices are categorized and must receive manufacturing licenses and marketing approval from the TGA. Clinical trials are regulated through the Clinical Trial Exemption or Notification Schemes. The Pharmaceutical Benefits Scheme subsidizes prescription drugs that meet criteria including medical need and cost-effectiveness. Advertising of medicines is regulated and direct-to-consumer advertising of prescription drugs is prohibited. Patents lasting 20 years can protect pharmaceutical innovations if they are novel, inventive and useful. Trademarks lasting 10 years distinguish goods and services. Product liability draws from common law and federal and state statutes.
IPO Fast Forward 2013: Medical Apps Event @ Maidstone & Tunbridge Wells NHS Trust. UK Medical Device regulator presentation from Rob Higgins, MHRA.gov.uk (Reproduced with permission)
Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
The document provides an overview of the Therapeutic Goods Advertising Code (No. 2) 2018. It discusses the background and legislative framework for advertising therapeutic goods in Australia, including the Therapeutic Goods Act 1989 and Competition and Consumer Act. Key points covered include definitions of terms in the Code like 'health warning' and what constitutes advertising. It also summarizes the differences between the 2015 and 2018 versions of the Code, such as updated mandatory information requirements and changes to prohibited representations. Overall, the document aims to outline and explain the purpose and requirements of the Therapeutic Goods Advertising Code.
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
This document discusses biovigilance, which refers to the science and activities related to monitoring biological products for adverse events and quality issues. It provides definitions for biological products and outlines the regulatory framework in Australia. The responsibilities of sponsors to report adverse events, recalls, and maintain traceability systems are described. Examples of adverse events reported for tissue products are given. The document notes that draft biovigilance guidance has been developed and will undergo public consultation before being finalized.
The document summarizes pharmacovigilance in Australia. It describes Australia's health care system and spending, the leading causes of illness and death, and key events that led to the establishment of pharmacovigilance guidelines and committees. It provides details on guidelines adopted from the EU and ICH, adverse drug reaction reporting procedures to the TGA and ADRAC, and statistics on reported adverse events.
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
Cliniminds- Skill Development Program in PharmacovigilanceCliniminds India
CLINIMINDS brings to you an intensive course covering all the aspects of case processing, specially designed for Pharmacovigilance professional.
Our training program involves:
1. Fresher training for Drug Safety Associate with Hands On experience on safety database
2. Training on Case Processing
3. Training on Aggregate Reporting with Hands On
experience in PSUR/ PBRER writing
4. Training on Signal Detection and Risk Management
5. Training on Regulatory Affairs on Audits
6. Training Medical and Scientific Content Writing
7. Customized Training on Pharmacovigilance (Designed exclusively for Corporate who need domain knowledge on specific area (s) of pharmacovigilance)
The document discusses pharmacovigilance, which is defined as the science of detecting, assessing, understanding, and preventing adverse effects of medicines. It describes the history of pharmacovigilance, including the thalidomide tragedy in the 1960s which led to increased regulation. The document outlines pharmacovigilance in Pakistan, including the establishment of an online reporting system by DRAP in 2018 for healthcare professionals and patients to report adverse drug reactions. It provides key terms related to pharmacovigilance and describes the pharmacovigilance workflow and functions.
Regulation of Nanomedicines by the Therapeutic Goods AdministrationTGA Australia
This presentation describes how nanomedicines are regulated in Australia, and summarises activities under the National Nanotechnology Strategy designed to gauge and build our ongoing regulatory capacity for nanotherapeutics (including sunscreens)
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code ...TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections. Information about which version of the Code will apply to advertisements for the purposes of advertising pre-approval and complaints handling is also provided, along with information about the enforcement discretion policy the TGA will apply in 2019 for complaints about advertisements that do not comply with the Code.
TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code ...TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections. Information about which version of the Code will apply to advertisements for the purposes of advertising pre-approval and complaints handling is also provided.
The document outlines the regulation of medicines in South Africa. It discusses the key pieces of legislation, the Medicines Control Council (MCC) mandate to regulate medicines, clinical trials, and manufacturers. It also covers flexibilities in the law around access like compassionate use. Current challenges include inspection capacity and emerging areas like advanced therapies. Regulation of biosimilars follows EMA guidelines largely. Global cooperation among regulators is important for efficiency and responsiveness.
Presentation: The challenges of regulating direct to consumer digital medical...TGA Australia
The document discusses the challenges of regulating direct-to-consumer digital medical devices. It describes what digital medical devices are, including connected devices, telehealth, apps, and wearables. The Therapeutic Goods Administration (TGA) regulates medical devices in Australia to ensure they are safe and effective. However, digital devices pose new challenges as many are software-based and consumers may not understand their intended medical purpose. The TGA must determine how to appropriately apply existing regulations to these new technologies.
An introduction to the work of Australia’s regulator of therapeutic goodsTGA Australia
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia to protect public health and safety. The TGA evaluates medicines, medical devices, and other therapeutic goods before and after market approval based on quality, safety, efficacy, and risk level. It maintains a register of approved products and monitors the market, responding to issues that arise. In the future, regulation may be conducted jointly with New Zealand under a single agency.
Better medicine labels: New requirements under TGOs 91 and 92TGA Australia
The document discusses new requirements for medicine labels under Therapeutic Goods Orders 91 and 92. Key points include:
1) The orders aim to improve safety and quality use of medicines by ensuring important health information is consistently located and not obscured on labels.
2) They require active ingredients to be prominently displayed, introduce a transition period until 2020 when TGO 69 is replaced, and establish two orders - one for prescription medicines and one for non-prescription.
3) Changes include larger active ingredient text, mandatory space for pharmacy labels on prescription medicines, and listing critical health information for non-prescription medicines.
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
Manufacturing Investigational Medicinal Products - Legislative and GMP requir...TGA Australia
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
Australia has strict regulations for pharmaceuticals and medical devices overseen by the Therapeutic Goods Administration (TGA). Medicines and devices are categorized and must receive manufacturing licenses and marketing approval from the TGA. Clinical trials are regulated through the Clinical Trial Exemption or Notification Schemes. The Pharmaceutical Benefits Scheme subsidizes prescription drugs that meet criteria including medical need and cost-effectiveness. Advertising of medicines is regulated and direct-to-consumer advertising of prescription drugs is prohibited. Patents lasting 20 years can protect pharmaceutical innovations if they are novel, inventive and useful. Trademarks lasting 10 years distinguish goods and services. Product liability draws from common law and federal and state statutes.
IPO Fast Forward 2013: Medical Apps Event @ Maidstone & Tunbridge Wells NHS Trust. UK Medical Device regulator presentation from Rob Higgins, MHRA.gov.uk (Reproduced with permission)
Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
The document provides an overview of the Therapeutic Goods Advertising Code (No. 2) 2018. It discusses the background and legislative framework for advertising therapeutic goods in Australia, including the Therapeutic Goods Act 1989 and Competition and Consumer Act. Key points covered include definitions of terms in the Code like 'health warning' and what constitutes advertising. It also summarizes the differences between the 2015 and 2018 versions of the Code, such as updated mandatory information requirements and changes to prohibited representations. Overall, the document aims to outline and explain the purpose and requirements of the Therapeutic Goods Advertising Code.
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
This document discusses biovigilance, which refers to the science and activities related to monitoring biological products for adverse events and quality issues. It provides definitions for biological products and outlines the regulatory framework in Australia. The responsibilities of sponsors to report adverse events, recalls, and maintain traceability systems are described. Examples of adverse events reported for tissue products are given. The document notes that draft biovigilance guidance has been developed and will undergo public consultation before being finalized.
The document summarizes pharmacovigilance in Australia. It describes Australia's health care system and spending, the leading causes of illness and death, and key events that led to the establishment of pharmacovigilance guidelines and committees. It provides details on guidelines adopted from the EU and ICH, adverse drug reaction reporting procedures to the TGA and ADRAC, and statistics on reported adverse events.
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
Cliniminds- Skill Development Program in PharmacovigilanceCliniminds India
CLINIMINDS brings to you an intensive course covering all the aspects of case processing, specially designed for Pharmacovigilance professional.
Our training program involves:
1. Fresher training for Drug Safety Associate with Hands On experience on safety database
2. Training on Case Processing
3. Training on Aggregate Reporting with Hands On
experience in PSUR/ PBRER writing
4. Training on Signal Detection and Risk Management
5. Training on Regulatory Affairs on Audits
6. Training Medical and Scientific Content Writing
7. Customized Training on Pharmacovigilance (Designed exclusively for Corporate who need domain knowledge on specific area (s) of pharmacovigilance)
The document discusses pharmacovigilance, which is defined as the science of detecting, assessing, understanding, and preventing adverse effects of medicines. It describes the history of pharmacovigilance, including the thalidomide tragedy in the 1960s which led to increased regulation. The document outlines pharmacovigilance in Pakistan, including the establishment of an online reporting system by DRAP in 2018 for healthcare professionals and patients to report adverse drug reactions. It provides key terms related to pharmacovigilance and describes the pharmacovigilance workflow and functions.
Regulation of Nanomedicines by the Therapeutic Goods AdministrationTGA Australia
This presentation describes how nanomedicines are regulated in Australia, and summarises activities under the National Nanotechnology Strategy designed to gauge and build our ongoing regulatory capacity for nanotherapeutics (including sunscreens)
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code ...TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections. Information about which version of the Code will apply to advertisements for the purposes of advertising pre-approval and complaints handling is also provided, along with information about the enforcement discretion policy the TGA will apply in 2019 for complaints about advertisements that do not comply with the Code.
TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code ...TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections. Information about which version of the Code will apply to advertisements for the purposes of advertising pre-approval and complaints handling is also provided.
TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
The document provides background information on Australia's Therapeutic Goods Advertising legislation and Code. It discusses key aspects of the legislation including:
- The Therapeutic Goods Act and Regulations set advertising requirements for therapeutic goods. Advertising must also comply with the Australian Consumer Law.
- The Act prohibits off-label promotion and requires pre-approval of medicine ads in certain media. It also places restrictions on advertising certain medical conditions.
- The Therapeutic Goods Advertising Code provides the framework for ensuring advertising is conducted properly and does not mislead consumers. It was recently revised to provide more clarity.
- The Code applies broadly to any advertising of therapeutic goods. It exempts genuine news reporting and ads directed to health
TGA presentation: Advertising therapeutic goods to consumers - Complying with...TGA Australia
An overview of the legislative framework that the TGA administers to regulate the advertising of therapeutic goods, including an exploration of key concepts, such as why advertising is regulated, the definition of ‘advertise’, food-medicine and cosmetic-medicine interface issues, prohibited representations and restricted representations.
TGA presentation: What pharmacies need to know about advertising therapeutic ...TGA Australia
An overview of the legislative landscape for pharmacies wanting to advertise therapeutic goods in 2019. Includes a brief overview of the advertising legislation, followed by a summary of the TGA's new advertising complaints handling framework, tips for pharmacies to ensure compliant advertising and how to find more information.
Devices Sponsor Information Day: 5 - Post-market - Advertising therapeutic go...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
This document provides an overview of changes to regulations around advertising of non-prescription medicines and complementary medicines in Australia. Key changes include: increased clarity and objectivity in the new Therapeutic Goods Advertising Code; new mandatory statements and health warnings; ending of mandatory pre-approvals by 2020 and replacing it with an advisory service; and heavier sanctions and penalties for non-compliance. Marketers have raised concerns around requirements for social media, testimonials, and implied claims. Tips are provided to help marketers avoid common breaches, such as thoroughly understanding products and indications and the new code requirements.
Presentation: Advertising cosmetic injectables - Complying with the therapeut...TGA Australia
The TGA regulates therapeutic goods in Australia, including cosmetic injectables. Advertisements for cosmetic services using Schedule 4 substances like botulinum toxin and hyaluronic acid are prohibited from mentioning the trade names, ingredients, or abbreviations of these substances. To comply, advertisements cannot specify products by name, ingredients, or acronyms and the TGA provides educational resources to help advertisers. Non-compliance may result in penalties and the TGA seeks initially to educate advertisers before regulatory action.
This document provides an overview of Volume 9A which contains guidelines for pharmacovigilance of medicinal products for human use in the EU. It defines pharmacovigilance and describes the roles and responsibilities of marketing authorization holders, competent authorities, and the EMA. Key aspects covered include pharmacovigilance systems, signal detection, safety reporting, risk management plans, and safety communication.
Update on the therapeutic goods advertising reforms - webinarTGA Australia
This document summarizes updates to Australia's therapeutic goods advertising reforms which aim to improve consumer safeguards around medicine and medical device advertising. Key changes include a new Therapeutic Goods Advertising Code, single complaints handling process, enhanced penalties, and education resources. Advertisers will have a transition period until mid-2020 to comply with the new rules which are designed to increase clarity, support enforcement, and prioritize complaints by public health risk. The reforms establish new criminal offenses, civil penalties, and processes for addressing non-compliant advertising.
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
Presentation on the legal implications & compliance in the sales & marketing of medical devices in Europe given at the 3rd annual Medical Device Reimbursement Conference in Brussels (Q1 Productions, January 24th, 2012)
This administrative order from the Department of Health of the Philippines establishes guidelines for the promotion and marketing of prescription pharmaceutical products and medical devices. It aims to ensure medical decisions are made in the best interest of patients and uphold patient rights and welfare. The order prescribes standards for information dissemination, advertising, and other promotional activities involving prescription drugs and medical devices. It applies to all entities engaged in promotion of these products and aims to ensure ethical interactions between industry and other stakeholders in line with principles of healthcare focus, integrity, independence, legitimacy, transparency, accountability, appropriateness, and advancement.
TGA Presentation: Medicines scheduling and scheduling policy ad hoc working g...TGA Australia
TGA Scheduling Working Group Meeting One February 2018. Role of the Working Group including Reforms to the advertising of S3 pharmacist only medicines, Reviewing what current S3 substances should be advertised, Proactively identifying S4 medicine substances for consideration for down-scheduling, Adding a new appendix to the poison standard to provide additional safeguards when down-scheduling
The document provides an overview of regulations and guidelines around the promotion of medical devices in Germany, the Netherlands and the UK. It discusses regulatory requirements, misleading and comparative advertising laws, industry codes of practice, and alternatives to legal action such as making complaints to regulatory or advertising standards authorities. Key points covered include the need for CE marking, restrictions on claims, guidelines around providing information versus promotional materials, and dealing with competitors' advertising claims.
The document discusses key aspects of the proposed Therapeutic Products Bill as it relates to medical devices. It provides an overview of the purpose and design of the bill, definitions of key terms like "therapeutic product" and "medical device", risk classification of devices, and conformity assessment procedures. It notes that the bill is intended to regulate medical devices across their lifecycle from design and development to supply and post-market activities like adverse event reporting. It also outlines different proposed approval pathways for medical devices.
This document discusses challenges and potential solutions related to market access for medical devices. Some key challenges include creating and communicating value to stakeholders, varied decision-making criteria across countries, technological evolution outpacing regulation updates, resource constraints in healthcare systems, lack of stakeholder engagement, and lack of evidence on economic value. Potential solutions proposed are focusing on health technology assessment processes, utilizing HTA groups as knowledge resources, reforming regulatory processes, increasing stakeholder involvement, using real-world data to drive device design and adoption, and effectively communicating value to end-users. Future trends may include increased combination products that integrate drugs, devices and/or biologics.
This document discusses challenges and potential solutions related to market access for medical devices. Some key challenges include creating and communicating value to stakeholders, varied decision-making criteria across countries, technological evolution outpacing regulatory updates, resource constraints in healthcare systems, lack of stakeholder engagement, and lack of evidence on economic value. Potential solutions proposed are focusing on health technology assessment processes, utilizing HTA groups as resources, reforming regulatory processes, increasing stakeholder involvement, using real-world data to drive device design and adoption, and effectively communicating value to end-users. Future trends may include increased combination products that integrate drugs, devices and/or biologics.
This document provides an overview of direct-to-consumer advertising (DTCA) of prescription drugs. It defines DTCA as pharmaceutical companies promoting prescription drugs directly to consumers through television, radio, print or online ads. The goals of DTCA are to inform consumers about diseases and treatment options and encourage patients to talk to their doctors. While DTCA increases disease awareness and treatment information for patients, it may also lead to patient self-diagnosis and pressure on doctors to prescribe advertised drugs. The FDA regulates DTCA in the US, while countries like New Zealand have debated banning it due to concerns about misleading ads and increased healthcare costs.
Similar to Therapeutic Goods Advertising Code (No. 2) 2018 (20)
The challenges of regulating direct to consumer digital medical devicesTGA Australia
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing
Updates from the Pharmacovigilance and Special Access Branch TGA Australia
Presentation on using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program (PVIP) update, International collaboration activities, Adverse Event Management System (AEMS)
Q and A
Regulatory updates from the Complementary and OTC Medicines Branch - Listed m...TGA Australia
The document discusses several regulatory reforms for listed medicines in Australia, including:
1. Permitted indications which provide a list of approved health benefit claims for listed medicines and require sponsors to select from this list, improving transparency.
2. An assessed listed pathway which allows pre-market evaluation of efficacy claims, providing access to higher-level health claims.
3. A "TGA assessed" label claim indicating the medicine's efficacy has been evaluated, improving consumer awareness and confidence.
4. Two years of market exclusivity for sponsors who apply for and are approved for new permitted ingredients.
Regulation, ethics and reimbursement of novel biological therapies in Austral...TGA Australia
The document provides an overview of novel biological therapies such as gene therapy, cell therapy, and tissue engineering in Australia. It discusses the regulatory pathways through the Therapeutic Goods Administration (TGA) for approval of these therapies. Clinical trials of novel biological therapies must be submitted through the CTX scheme for approval rather than just notification. Guidelines from the European Medicines Agency are a good resource for requirements for registration and approval of these therapies in Australia. Risks associated with gene therapy include potential for delayed adverse effects, off-target effects, insertional mutagenesis, and immune responses.
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Regulatory updates from the TGA Medical Devices Branch - Part 1TGA Australia
Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring
Regulatory updates from the TGA Medical Devices Branch - Part 2TGA Australia
The document summarizes proposed regulatory reforms from the Therapeutic Goods Administration (TGA) Medical Devices Branch. It discusses proposed changes to the regulation of software as medical devices, personalized medical devices including 3D printed devices, essential principles, conformity assessment procedures, requirements for devices used in clinical trials, and clarifying requirements for systems and procedure packs. The proposed reforms aim to modernize regulations, increase alignment with international standards, and ensure oversight is risk-based and promotes safety. Public consultations will be held on the proposed changes.
SME Assist: Help to navigate the regulatory mazeTGA Australia
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
TGA webinar: The Good Manufacturing Practice (GMP) Clearance Framework – an o...TGA Australia
The document provides an overview of Australia's Good Manufacturing Practice (GMP) Clearance Framework. It discusses the legislative basis for manufacturing requirements, the roles and activities of the Manufacturing Quality Branch, and the two pathways for obtaining a GMP Clearance - a desk-based assessment through a Mutual Recognition Agreement or Compliance Verification, or an on-site TGA inspection. It also outlines the history of GMP Clearance, recognized authorities through agreements like MRAs, and the MRA assessment pathway.
Webinar presentation: Consultation on reforms to the generic medicine market ...TGA Australia
The TGA is consulting on reforms to streamline the generic medicine market authorisation process. The proposed reforms include: 1) Reducing regulatory barriers such as relaxing requirements for dissolution data and reference products in bioequivalence studies. 2) Providing more certainty on data requirements through early advice on biowaiver justifications. 3) Supporting international work sharing by using common templates for bioequivalence studies and biowaiver justifications. 4) Prioritizing applications for generic medicines that address shortages or high expenditure to encourage more competition. Feedback is sought through an online consultation closing March 21. The reforms aim to enhance supply of affordable generic medicines in Australia.
Presentation: Software as a Medical Device: Regulatory insights and Q & ATGA Australia
The document provides an overview of the Therapeutic Goods Administration (TGA) in Australia, which regulates medical devices and software. It discusses:
- The TGA evaluates medical devices before and after market to ensure safety, quality and performance.
- Medical devices are classified based on risk from Class I to III, with Class III requiring the most oversight and pre-market evaluation.
- All medical devices must comply with the Essential Principles which address design, safety and intended use. Higher risk devices require more regulatory procedures.
- Software can be regulated as a medical device (Software as a Medical Device or SaMD) if it meets the definition and new rules are being proposed for SaMD in Australia
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...TGA Australia
The document summarizes the results of a consultation on proposed reforms to the regulation of software as a medical device in Australia. It discusses key points from international approaches to classifying and regulating software, proposed new classification rules and essential principles for software in Australia, and the results of the consultation which found general agreement with the proposals among respondents.
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.
Presentation Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TG...TGA Australia
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
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- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
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There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
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Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
1. Therapeutic Goods Advertising Code (No. 2) 2018
The Code basics
Advertising Education and Assurance Section
Regulatory Education and Compliance Branch
Regulatory Practice and Support Division
ACCORD 15 March 2019
3. Therapeutic goods advertising legislation
• The advertising requirements are set out in the
– Therapeutic Goods Act
– Therapeutic Goods Regulations
– Therapeutic Goods Advertising Code
• Advertising is also subject to the Competition and Consumer Act (Australian
Consumer Law)
4. Compliance with advertising code
• Advertising to the public for therapeutic goods MUST comply with the
Advertising Code
• Requirement to comply with the Code is specified through a criminal offence
and civil penalty provision in the Act:
– Section 42DM – criminal offence
– Section 42DMA – civil penalty
• For an ad to be approved under the Regulations (5G), the delegate must be
satisfied that it complies with the Code
3
5. Role of the advertising code
• The Code is the cornerstone of the advertising framework
– Requires that advertising supports appropriate use of therapeutic goods
and does not mislead or deceive
• Advertising Code (No.2) 2018 took effect on 1 January 2019
• The Code was revised to provide clarity and more objective tests to support
sanctions and penalties
4
7. • “Cosmetic” products are not intended to be “therapeutic goods”
• Cosmetics are regulated under legislation administered by the National Industrial
Chemicals Notification & Assessment Scheme (NICNAS):
– the Industrial Chemical Notification Act 1990 (ICNA Act)
• Further information see www.nicnas.gov.au
Interface issues - Cosmetic products
9. • A cosmetic:
‒ must meet the definition of “cosmetic” in the ICNA Act
‒ cannot be a ‘therapeutic good’ within the meaning of the Therapeutic Goods
Act 1989
– i.e. must not be for therapeutic use
– therapeutic use includes preventing, diagnosing, curing or alleviating a
disease, ailment, defect or injury in persons, influencing physiological
processes
Interface issues - Cosmetic products
12. Interface issues – Cosmetic products
• Making therapeutic claims about regular consumer goods may bring
them into TGA’s jurisdiction
• This includes claims such as:
– stating a product can modify a biological function
– implying the product can cure, treat or diagnose a disease
• We work closely with other regulators including ACCC and NICNAS
11
16. Structure of the 2018 code
• Part 1 – Preliminary – definitions, object, application
• Part 2 – General requirements for advertising therapeutic goods
• Part 3 – Specific rules relating to particular therapeutic goods
• Part 4 – Prohibited & restricted representations
• Schedule 1 – Medicines with specific health warnings
• Schedule 2 – Advertising to children
• Schedule 3 – Samples
• Schedule 4 – Price information
• Schedule 5 – Repeals
15
18. Section 4 - Definitions
• It is important to read the Code in conjunction with the Act and the
Therapeutic Goods Regulations 1990
– Terms that are not defined in the Code may be defined in the Act and
Regulations (e.g. ‘advertise’)
• Most Code definitions straightforward but there are some that we will explore
in detail:
– Health warning
– Prominently displayed or communicated
17
19. Definition of ‘advertise’
“…in relation to therapeutic goods, includes make any statement, pictorial representation or design
that is intended, whether directly or indirectly, to promote the use or supply of the goods, including
where the statement, pictorial representation or design:
(a) is on the label of the goods; or
(b) is on the package in which the goods are contained; or
(c) is on any material included with the package in which the goods are contained.”
18
20. What are health warnings?
• In some cases, health warnings need to be included in ads
• Concept of ‘health warning’ is defined in s.4 of the Code
• The purpose of health warnings is to alert consumers to information that will
be critical to the consumer's assessment of whether the advertised product is
right for them before purchase
19
21. Health warning definition - Medicines
• Health warnings for medicines are prescribed in Schedule 1 of the Code
• Schedule 1 health warnings are:
– an exhaustive list but may be updated from time to time
– based on RASML, permitted ingredients determination, TGO69 and TGO92
– divided into different parts for warnings for registered medicines, listed
medicines and both types of medicines
20
22. Example of medicine health warnings
1. Ingredients 2. Circumstances 3. Health warning
Hydroxyanthracene derivatives such as
those from:
• Aloe
• Buckthorn
• Cascara
• Frangula
• Rhubarb
• Senna
In preparations for oral use where the
MRDD contains MORE than 10mg
Do not use if you have abdominal pain,
nausea, vomiting or diarrhoea
Ibuprofen/paracetamol combinations In preparations for oral use Do not use if you have a stomach ulcer,
impaired kidney function, heart failure,
allergic to anti inflammatory medicines,
pregnant or trying to become pregnant
21
23. Health warning definition – Devices/OTGs
…a statement that is required under the Act or Regulations or Medical Devices Regulations to
be included on the label or in instructions for use that warns that a person who takes or uses the
device or goods as intended may:
(i) die; or
(ii) require hospitalisation or a longer period of hospitalisation than would be required if the
person had not taken or used the device or goods; or
(iii) require a medical practitioner to treat or prevent injury, disability, incapacity or impairment of
any bodily function, organ or structure as a consequence of taking or using the device or goods
22
24. Prominently displayed or communicated
‘prominently displayed or communicated’ is defined as:
(a) either:
(i) for a visual statement—standing out so as to be easily read from a
reasonable viewing distance for the particular media type in the context in
which the advertisement is intended to be viewed; or
(ii) for a spoken statement—able to be clearly heard and understood; and
(b) repeated as often as is necessary to ensure that it is likely to be
noticeable for a viewer or listener.
23
25. Section 5 – Object of the code
“...to ensure that the advertising of therapeutic goods to consumers is
conducted in a manner that:
(a) promotes the safe and proper use of therapeutic goods by minimising their
misuse, overuse or underuse; and
(b) is ethical and does not mislead or deceive the consumer or create
unrealistic expectations about product performance; and
(c) supports informed health care choices; and
(d) is not inconsistent with current public health campaigns.“
24
26. Section 6 – Application
• Applies to:
– The advertising of therapeutic goods (ss.6(1))
– By any person advertising or causing advertising (ss.6(5))
• Does not apply to:
– Genuine news (ss.6(6)) by certain bodies (ss.6(7)) – including
broadcasters, datacasters and publishers
– Advertising directed exclusively to health professionals (ss.6(2))
25
27. Application of specific sections of the code
• Certain sections and parts of the Code do not apply to:
– Labels (as defined in s.3 of the Act)
– Consumer medicine information leaflets (CMIs) – (defined in Regulations as
‘patient information documents‘)
– Patient information leaflets (PILs) - for implantable medical devices (see
Code - s.4 - Definitions)
• These exemptions are set out in the relevant sections of the Code
• These documents can still be considered promotional – if so, they have to
comply with all other relevant Code provisions
26
28. Section 6 – Application
• How to apply the Code to a particular advertisement:
– consider its likely impact on a reasonable person to whom the
advertisement is directed (ss.6(3))
– the total presentation and context of the advertisement is to be taken into
account (ss.6(4))
27
29. Audience advertisement directed to
• Advertising may be directed to the public in general or a sub-population
• A direction may be made in many forms, including:
– An overt statement e.g. “Do you suffer from mild eczema?”, “For the relief of
very dry skin”
– An implied call to capture the attention of a sub-population e.g. for the
measurement of blood pressure
– The location of the ad e.g. in a magazine for diabetics
28
30. Total presentation & context
• Total presentation: the advertisement as a whole
• Context includes:
– What other information is provided around the advertisement that could
change the take-out message? e.g. an editorial on a page opposite the
advertisement
– Does the environment in which it is displayed have the potential to alter the
take-out message? E.g. a billboard ad that is viewed when passing in a car
at speed
29
32. Section 6A & 6B – Repeals & transition
• Section 6A, by reference to Schedule 5, repeals the 2015 Code and the
original 2018 Code
• Section 6B allows for a transition period for ads pre-approved under the 2015
Code – i.e.
– Complaints about such ads will be assessed against the 2015 Code for the
life of the approval
31
33. Part 2 - Requirements for advertising all
therapeutic goods to the public
32
34. Section 8 – Approved ads
• Ads for medicines for ‘specified media’ (e.g. free-to-air television, newspaper,
billboard) require prior approval under Regulation 5G
– Arises from offence under section 42C of Act
• S.8 requires ads appearing in print media and billboards to display the
approval number in the advertisement as set out in ss.8(3) – must be legible
33
35. S.9 – Accuracy
Validity and substantiation
Advertising for therapeutic goods must satisfy the following:
(a) any claims made in the advertising are valid and accurate, and all
information presented has been substantiated before the advertising
occurs
Truthful and not misleading
Advertising for therapeutic goods must satisfy the following:
(b) it is truthful, balanced and not misleading or likely to mislead, including in
its claims, presentations, representations and comparisons
34
36. S.9 – Accuracy
Comparisons
Advertising for therapeutic goods must satisfy the following:
(c) any comparisons made in the advertising between therapeutic goods or
classes of therapeutic goods do not directly or indirectly claim that the
goods or class of goods being used as the comparator are harmful or
ineffectual;
Consistency with the ARTG
Advertising for therapeutic goods must satisfy the following:
(d) if the goods are included in the Register— it is consistent with the entry
for the therapeutic goods in relation to that inclusion.
35
37. S.10 – Effect
Support proper use
(a) Advertising for therapeutic goods must support the safe and proper use of therapeutic goods
by:
(i) presenting the goods in accordance with directions or instructions for use; and
(ii) not exaggerating product efficacy or performance;
Delaying proper treatment
(b) Advertising for therapeutic goods must…not be likely to lead to people delaying necessary
medical attention or delaying the use of, or failing to use, treatment prescribed by a medical
practitioner;
36
38. S.10 – Effect
Encourage inappropriate use
(c) Advertising for therapeutic goods must not encourage inappropriate or
excessive use of the therapeutic goods
Safe or cannot harm
(d) Advertising for therapeutic goods must not contain any claim, statement,
implication or representation that:
(i) the therapeutic goods are safe or that their use cannot cause harm, or
that they have no side-effects
37
39. S.10 – Effect
Sure cure
(d) Advertising for therapeutic goods must not contain any claim, statement, implication or
representation that…
(ii) the therapeutic goods are effective in all cases of a condition or that the outcome from
their use is a guaranteed or sure cure;
Miraculous
(d) Advertising for therapeutic goods must not contain any claim, statement, implication or
representation that…
(iii) the therapeutic goods are infallible, unfailing, magical or miraculous;
Example: A testimonial on a website for a sunscreen claiming that it completely blocks harmful
UV rays.
38
40. S.10 – Effect: harmful consequences
(d) Advertising for therapeutic goods must not contain any claim, statement,
implication or representation that…
(iv) harmful consequences may result from the therapeutic goods not being
used — unless the claim, statement, implication or representation is
permitted under section 42DK of the Act or approved under section 42DF of
the Act.
Example: Spending time in the sun without an SPF 30 can result in increased
incidence of skin cancer.
39
41. Sections 11 - 13
Mandatory information and
statements
40
42. Overview: application of sections
Section 11 Section 12 Section 13
Ad for S3 (App H) medicine
Ad for non-S3 therapeutic good that allows
purchase without seeing the good
(selected items
only)
Any other ad for non-S3 therapeutic good
Note: other provisions in the Code, including Part 3, will still apply in each case 41
43. S.11: Required statement – S3s
• An advertisement for a medicine containing a substance included in Schedule
3 of the Poisons Standard and Appendix H must prominently display or
communicate:
ask your pharmacist - they must decide if this product is right for you
• This is the only mandatory statement required by Part 2 for S3 ads
– Part 3 still applies – e.g. analgesics warning
• Does not apply to labels, CMIs or Patient Information Leaflets (PILs)
42
44. Overview of Section 12 & 13 requirements
Advertising must contain…
• Basic info about the goods
Information that needs to be prominently displayed or communicated:
• Important health information (or a prompt to consumers to read it)
• Advice to follow directions
• If there are symptoms claims in the ad - an appropriate symptom statement
43
45. S.12: What must ads contain (goods not available for inspection)
• This section is only for ads for goods that are not available for physical
examination by the consumer before or at the time of purchase (e.g. internet,
mail order marketing)
• Does not apply to:
– advertisements subject to section 11
– a label, CMIs or PILs
44
46. Section 12 mandatories for medicines
* Needs to be prominently displayed or communicated (as defined in s.4)
Type of info Provision and the information required in ad
Basic information about
the goods
• ss.12(3)(a) – (c) -the name of the medicine, dosage form, the quantity of the medicine
• ss.12(3)(d) - one or more of the indications for the medicine, as they appear on the medicine’s label
• ss.12(3)(e) - list of certain ingredients – see s.4 definition
Important health info * • ss.12(3)(f) – an alert to the consumer to read the label or warnings (as appropriate for the nature of
the medicine)
Follow the directions * • ss.12(3)(g) – ‘Follow the directions for use’ or ‘Follow the instructions for use’ from ss.13(6)
Symptom statement * • ss.12(3)(h) - If there are symptoms claims in ad, include appropriate statement/s from ss.13(7)
45
47. ss.12(3)(f): Important health info for medicines
No
Do you want to include the health warnings upfront
in the ad?
USE: ‘This medicine may not be right for you. Read the
warnings before purchase’
followed immediately by information about where the
health warnings can be found
USE: ‘Always read the label’ and
the health warnings
USE: ‘Always read the label’
Yes
No Yes
46
48. Section 12 mandatories: devices
Type of information Provision and the information required in ad
Basic information about the
goods
• ss.12(4)(a) – (b) – an accurate description and a reference to EITHER the trade name or another
name for the device
• ss.12(4)(c) – the intended purpose or indications for the device as they appear on label or
primary packaging
• ss.12(4)(d) - a list of the ingredients if applicable
Important health information * • ss.12(4)(e) – an alert to the consumer to read the label, instructions or warnings (as appropriate
for the device)
Follow the directions
statement *
• ss.12(4)(f) – ‘Follow the directions for use’ or ‘Follow the instructions for use’ from ss.13(6) as
appropriate for the device
Symptom statement * • ss.12(4)(g) - If there are symptoms claims in ad, include appropriate statement/s from ss.13(7)
* Needs to be prominently displayed or communicated (as defined in s.4)
47
49. ss.12(4)(e): Important info for devices
Are there statements on the label or instructions for use for the
device that meet the definition of ‘health warning’ in section 4 of
the Code?
Do you want to include the health warnings upfront
in the ad?
USE: ‘This product may not be right for you. Read the
warnings before purchase’
followed immediately by information about where the
health warnings can be found
USE: ‘Always read the
label/instructions for use’ and the
health warnings
USE: ‘Always read the
label/instructions for use’
NoYes
No Yes
48
50. Section 12 mandatories: OTGs
Type of information Provision and the information required in ad
Basic information about the
goods
• ss.12(5)(a) – (b) – an accurate description and a reference to EITHER the trade name or another
name for the goods
• ss.12(5)(c) – the intended purpose or indications for the goods as they appear on label or
primary packaging
• ss.12(5)(d) - a list of the ingredients where relevant
Important health information • ss.12(5)(e) – an alert to the consumer to read the label, instructions or warnings (as appropriate
for the goods)
Follow the directions statement • ss.12(5)(f) – ‘Follow the directions for use’ or ‘Follow the instructions for use’ from ss.13(6) as
appropriate for the goods
Symptom statement • ss.12(5)(g) - If there are symptoms claims in ad, include appropriate statement/s from ss.13(7)
* Needs to be prominently displayed or communicated (as defined in s.4)
49
51. ss.12(5)(e): Important info for OTGs
Are there statements on the label or instructions for use for the
goods that meet the definition of ‘health warning’ in section 4 of
the Code?
Do you want to include the health warnings upfront
in the ad?
USE: ‘This product may not be right for you. Read the
warnings before purchase’
followed immediately by information about where the
health warnings can be found
USE: ‘Always read the
label/instructions for use’ and the
health warnings
USE: ‘Always read the
label/instructions for use’
NoYes
No Yes
50
58. S.13: What must ads contain (general)
• This section is only for ads that:
– are for goods other than Schedule 3 medicines (see s.13(1)(d) - section 11
applies to these)
– do not facilitate purchase of the goods without the consumer being able to
inspect them (see s.13(1)(e) - section 12 applies to these)
• It does not apply to labels, consumer medicine information or a patient
information leaflet (s.13(1)(a) & (b))
57
59. S.13: What must ads contain (general)
• This section also does not apply to picture/price/point of sale ads (see
s.13(1)(c)) – i.e.:
– an advertisement displaying only the name or picture of therapeutic goods
or their price or point of sale, or any combination of these, provided the
advertisement does not contain or imply a claim relating to therapeutic use,
or any other representation
58
60. Section 13 mandatories: medicines
* Needs to be prominently displayed or communicated (as defined in s.4)
Type of information Provision and the information required in ad
Basic information about the
goods
• ss.13(2)(a) – (b) – a reference to the trade name of the medicine and one or more of the
indications as they appear on label
Important health information * • ss.13(2)(c) – an alert to the consumer to read the label, instructions or warnings (as appropriate
for the goods)
Follow the directions statement
*
• ss.13(6) – ‘Follow the directions for use’ or ‘Follow the instructions for use’ as appropriate for
the goods
Symptom statement * • ss.13(7) - If there are symptoms claims in ad, include appropriate statement/s
59
61. ss.13(2)(c): Important info for medicines
Are there health
warnings in
Schedule 1 of the
Advertising Code
for the medicine?
Do you want to include
the health warnings in
the ad?
USE: ‘This medicine may
not be right for you. Read
the label before purchase’
USE: ‘Always read the label’ and the
health warnings
USE: ‘Always read the
label’
No
Yes
No
Yes
60
62. Section 13 mandatories: devices
Type of information Provision and the information required in ad
Basic information about the
goods
• ss.13(3)(a) – (b) – an accurate description and a reference to EITHER the trade name or another
name for the device
• ss.13(3)(c) – the intended purpose or indications for the device
Important health information * • ss.13(3)(d) – an alert to the consumer to read the label, instructions or warnings (as
appropriate for the device)
Follow the directions statement
*
• ss.13(6) – ‘Follow the directions for use’ or ‘Follow the instructions for use’ as appropriate for
the device
Symptom statement * • ss.13(7) - If there are symptoms claims in ad, include appropriate statement/s
* Needs to be prominently displayed or communicated (as defined in s.4)
61
63. ss.13(3)(d): Important info for devices
Are there statements on the label or instructions for use for the device that meet the
definition of ‘health warning’ in section 4?
Do you want to include the health warnings
in the ad?
USE: ‘This product may not be right for you. Read the
label/instructions for use before purchase’
depending on whether there is a label visible on primary pack
USE: ‘Always read the
label/instructions for use’
and the health warnings
USE: ‘Always read the
label/instructions for use’
NoYes
No Yes
62
64. Section 13 mandatories: OTGs
Type of information Provision and the information required in ad
Basic information about the
goods
• ss.13(4)(a) – (b) – an accurate description and a reference to EITHER the trade name or another
name for the goods
• ss.13(4)(c) – the intended purpose or indications for the goods
Important health information * • ss.13(4)(d) – an alert to the consumer to read the label or instructions (as appropriate for the
goods)
Follow the directions statement
*
• ss.13(6) – ‘Follow the directions for use’ or ‘Follow the instructions for use’ as appropriate for
the goods
Symptom statement * • ss.13(7) - If there are symptoms claims in ad, include appropriate statement/s
* Needs to be prominently displayed or communicated (as defined in s.4)
63
65. ss.13(4)(d): Important info for OTGs
Are there statements on the label or instructions for use for the goods that meet the
definition of ‘health warning’ in section 4?
Do you want to include the health warnings in the
ad?
USE: ‘This product may not be right for you. Read the
label/instructions for use before purchase’
depending on whether there is a label visible on primary pack
USE: ‘Always read the
label/instructions for use’
and the health warnings
USE: ‘Always read the
label/instructions for use’
NoYes
No Yes
64
66. Exemptions from parts of section 13: short form ads
• “Short form ads” are:
– Radio commercials 15 seconds or less duration
– Text-only ads of 300 characters or less with no ability to include pictures,
logos or other imagery
• Short form ads are exempt from:
– Important info – ‘Always read the label’ etc
– Symptoms statement (ss.13(6))
65
68. Example 1 - Bean’s tonic
An example of prominently
displayed mandatories for a
medicine without health warnings
67
69. Example 2 - Bean’s tonic
An example of prominently
displayed mandatories for a
medicine with health warnings -
using mandatories option 1 in
s.13(2)(c) of the Code
68
70. Example 3 - Bean’s tonic
An example of prominently
displayed mandatories for a
medicine with health warnings –
using mandatories option 2 in
s.13(2)(c) of the Code
69
71. Example 4 - Bean’s tonic
Will not be compliant under the
Code
70
75. S.15: Scientific or clinical representations
• Ss.15(1) - this section does not apply to labels, CMIs or PILs
• This section is in two parts:
– Requirements for use of scientific or clinical claims (ss.15(2))
– Requirements for use of citations (ss.15(3))
74
76. S.15(2): Scientific or clinical claims
Where an advertisement makes a scientific or clinical claim:
• (a) any scientific or clinical terminology must be appropriate, clearly
communicated and able to be readily understood by the audience to whom it
is directed; and
• (b) any scientific or clinical representation must be consistent with the body of
scientific or clinical evidence applicable to the advertised therapeutic goods.
75
77. S.15(3): Scientific citations
Where an advertisement contains a citation to scientific or clinical literature,
either explicitly or impliedly:
• (a) any research results must identify the researcher and financial sponsor of
the research, where the advertiser knows, or ought reasonably to have known
that information; and
• (b) the study must be sufficiently identified to enable consumers to access it.
76
78. Example Implied scientific
citation – reference
needs to be
provided
Scientific
information is
inappropriate and
won’t be readily
understood
These would need
to reflect the body
of evidence
available
77
80. S.16(1): Endorsements
• The endorsement provisions in section 16 do not apply to:
– Testimonials captured by section 17 (s.16(1)(a))
– Claimer for efficacy assessed non-prescription medicines – as described in
Regulations (s.16(1)(b))
79
81. S.16(2) and (2A): Endorsements
• Endorsements (express or implied) from the following are prohibited:
(a) a government authority, hospital or healthcare facility; or
(b) an employee or contractor of a government agency, hospital or healthcare
facility; or
(c) a health practitioner, health professional, medical researcher or a group of
such persons.
• Health care facilities do not include community pharmacies
80
82. S.16(3): Endorsements
Subject to conditions, endorsements from the following are permitted:
(a) an organisation that:
(i) represents the interests of healthcare consumers; or
(ii) represents the interests of health practitioners, health professionals or
medical researchers; or
(iii) conducts or funds research into any disease, condition, ailment or defect; or
(b) an employee or contractor of an organisation mentioned above, other than an
individual mentioned in paragraph (2)(b) or (c)
81
83. S.16: Endorsement conditions
• Endorsements made under s.16(3) are subject to the conditions that the
advertisement:
– names the organisation concerned; and
– discloses:
(i) the nature of the endorsement; and
(ii) whether the organisation or employee, has received, or will receive,
any valuable consideration for the endorsement
• ‘Organisation’ defined in s.16(4) – any group, association etc
82
84. S.17: Testimonials
• Testimonial = a statement about a therapeutic good made by a person that
claims to have used that good (s.17(1))
• This section of the Code specifies three types of requirements:
– Characteristics of the person making testimonial (s.17(2)(a))
– Obligations of the advertiser before using testimonial in advertising
(s.17(2)(b) and (c))
– Information that must be disclosed in the ad about the testimonial (s.17(3))
• When is a testimonial on social media considered to have been ‘used’ in an
advertisement?
83
85. Example acceptable use policy
We welcome your comments on our page but we ask that you help us comply with the Therapeutic Goods Advertising Code (the Code).Please
consider these guidelines before commenting. We will remove any comments that may result in us breaching the Code.
We love when you comment and tag your friends and family on our posts but we ask that you do not:
endorse our product if you are:
o an employee or contractor of a government authority, a hospital or a healthcare facility
o a health practitioner, health professional or medical researcher
o involved with the production, sale, supply or marketing of our product
o not using your own name on this social media platform.
imply that a government authority, a hospital or a healthcare facility endorse our product
make comments about how a product works for you outside of its intended purpose, as these comments can be dangerous or
misleading.—our products are developed for particular purposes, as stated on the label and/or in our advertising, and these comments can
be dangerous and misleading
• make comments about serious conditions, diseases, ailments or defects, such as comments about how a product helped with your cancer
treatment or how it will relieve a tagged person’s rheumatoid arthritis pain
We also have an obligation to make sure any advertisements we make, including endorsements and testimonials, are not misleading. Therefore
we promise to disclose:
where a person has been, or will be, compensated for making a testimonial
where we have actors making the testimonial, such as in cases where the original person who made the testimonial does not want to
appear in our advertisement
where the person making the testimonial is an immediate family member of anyone employed by our business 84
86. Who can make a testimonial for use in ads?
s.17(2)(a) - a person:
(i) whose details are verified prior to the advertising occurring; and
(ii) who has used the goods for their intended purpose; and
(iii) who is not:
(A) involved with the production, sale, supply or marketing of the goods; or
(B) an employee or officer of a corporation that is involved with the
production, sale, supply or marketing of the goods; or
(C) a corporation; or
(D) mentioned in subsection 16(2) (e.g. health professionals, staff from
government agency, hospital or healthcare facility)
85
87. Advertiser obligations when using testimonials
s.17(2)(b) and (c) – the advertiser needs to ensure that they have:
• verified as to the use of the goods and the claims made by the person prior to
the advertising occurring; and
• checked that the testimonial is typical of the results to be expected from the
use of the goods in accordance with the directions for use, or purpose, of the
goods.
86
88. Information re testimonials to be included in ads
s.17(3) – An ad containing a testimonial must:
(a) disclose whether the person providing the testimonial has received, or will
receive, any valuable consideration for the testimonial;
(b) disclose where another person is taking the place in the advertisement of
the person providing the testimonial; and
(c) disclose where the person providing the testimonial is an immediate family
member of an individual who is involved with the production, sale, supply or
marketing of the goods.
87
89. S.18: Incentives
• Ads must not offer any personal incentive to a pharmacy assistant, or any
retail sales person who is not a health professional, to recommend or supply
therapeutic goods.
• Pharmacy assistants and other retail staff do not meet the criteria for ‘health
professionals’ for the purposes of the advertising (s.42AA)
• Ads for these audiences must comply with the Code – including this provision
88
90. S.19: Advertising to children
• Advertising must not be primarily directed to children
under the age of 12 years at all
• Advertising must not be primarily directed to children aged
12 years or over, EXCEPT for those products listed in
Schedule 2 of the Code, which include tampons, sunscreens and
condoms
• Labels are excluded from this provision
• ‘primarily directed’ does not include incidental exposure
89
91. S.20: Samples
• An ad must not contain an offer of a sample EXCEPT for those products listed
in Schedule 3:
condoms
Sunscreens
Stoma devices for self-management
Continence catheter devices for self-management
• Samples can in themselves be an ad – consider Act definition of ‘advertise’
• Some samples may also be subject to state and territory laws – e.g.
scheduled substances
90
92. S.20: Samples example
Have you been diagnosed with IBS recently?
Wondering if you will ever find anything to help your
symptoms?
You can feel better in just two weeks – take the
Bean’s challenge!
Sign up at www.beanstonic.com.au and we will
email you a voucher for a free one month
supply of Bean’s Tonic from your local
pharmacy 91
93. S.21: Consistency with public health campaigns
• If a relevant public health campaign of which the advertiser knows, or ought
reasonably to have known is or will be current at the time of advertising
therapeutic goods, the advertising must not be inconsistent with the public
health campaign
• Campaigns can be current but not necessarily active – e.g. respiratory
hygiene campaigns only run in cold & flu season
• Guidance contains more information on establishing current public health
campaigns
92
94. S.21: Consistency with public health campaigns
Example: There are a
range of current initiatives
in Australia to encourage
responsible alcohol
consumption
Drinkers Delight
liver tonic
• improves liver function
• protects the liver from damage
from alcohol consumption –
especially on a big night out!
Cheers!
93
95. 94
Part 3 - Requirements when
advertising sunscreens
96. S.27 – Sunscreens
For an ad for a therapeutic good that is or contains a sunscreen that is claimed
to prevent sunburn or skin cancer, the ad must:
• depict sunscreens as being only one part of sun protection; and
• include statements or visual representations, prominently displayed or
communicated, to the effect that:
– prolonged high-risk sun exposure should be avoided; and
– frequent re-application or use in accordance with directions is required for
effective sun protection.
95
99. Part 4 – Restricted and
prohibited representations
98
100. Prohibited and Restricted Representations
• The Act makes it a criminal offence, and provides civil penalties, where an
advertiser makes reference certain conditions (explicitly, or by implication) in
advertising of therapeutic goods without prior approval:
– S. 42DL(7) and 42DLB(4) – restricted representations
– S. 42DL(5) and 42DLB(2) – prohibited representations
• The Act also provides that the Secretary may approve the use of these
representations under certain circumstances (s.42DF and s.42DK)
99
101. s.28(1)(a) – medically accepted
to be a form requiring
diagnosis, treatment or
supervision by a suitably
qualified health professional?
s.28(1)(a) - Once medically
diagnosed, is it medically
accepted to be suitable
for self-treatment and
management?
s.28(1)(b) - Is there a
diagnostic/screening, or other
kind of test for the form which
requires medical interpretation
or follow-up?
The form IS a
serious form
NOT a serious form
NO
YES YES
NO
NO
YES
100
102. Restricted representations
• A range of examples of what are and are not considered serious conditions are
provided in the Code guidance.
• The conditions included in the Code guidance make for a fairly easy
assessment of whether or not they need to be medically diagnosed.
• Where the serious condition is implied by the representation, this may be more
difficult to assess
101
103. Permitted restricted representations
• TGA has permitted the use of certain restricted representations by all
advertisers of therapeutic goods, where the ad and product meets the
characteristics and requirements specified.
• Permitted restricted representations include:
– Neural tube defect risk reduction in pregnancy when advertising medicines
with at least 400µg folic acid/day
– representations about sleep apnoea, Obstructive Sleep Apnoea (OSA) and
Central Sleep Apnea/Apnoea (CSA) in relation to Continuous Positive Airway
Pressure (CPAP) equipment
102
104. S.30 - Prohibited representations
• Representations (express or implied) about the treatment, cure, prevention,
diagnosis (including screening), monitoring or susceptibility of, or pre-
disposition to:
– Neoplastic diseases (i.e. all types of cancer)
– Sexually transmitted disease
– HIV/AIDS
– Hepatitis C virus
– Mental illness
• Abortifacient action
103
105. Using prohibited representations
• The use of a prohibited representation may be authorised where it is necessary
for either:
– Public health interest; or
– The appropriate use of the goods (packaging & labelling only)
• There is no process for applying to use prohibited representations – TGA will
identify where it is needed
• Representations about preventing transmission of STDs/HIV/AIDS and
prevention of skin cancer through sunscreen use are prohibited representations
but will be permitted
104
106. Restricted and prohibited representation approvals/ permissions
are published on the TGA website
105
108. What’s in our compliance toolkit?
Voluntary compliance
• Education program (further information about this later in the afternoon)
• Enquiry services
• Advertising pre-approvals remain until June 2020
Assisted compliance
• Obligations Notice – informs advertisers that their advertising may not be
compliant and advises them of their obligations
• Warning - informs advertisers that their advertising is non-compliant and advises
them of regulatory action that may be taken if they fail to respond/comply –
requires a written response
107
109. What’s in our compliance toolkit? (2)
Regulatory Compliance
• Substantiation Notice
• Directions Notice
• Cancellation or suspension of the therapeutic good from the ARTG
• Public Warning Notice
• Injunction from the Federal Court or Federal Circuit Court
• Infringement Notice
• Enforceable Undertaking
• Prosecution of a civil penalty provision
• Referral to the Commonwealth Director of Public Prosecutions for criminal prosecution
108
111. Code version applied in compliance
• For ads with current approval: version of Code approved under
• For ads (other than pre-approved ads) that occurred:
Advertising occurred Assessed against
On or after 1 January 2019 2018 code
Before 1 January 2019 and is no longer
occuring
2015 code
Before 1 January 2019 and is still occurring 2018 code
110
112. Compliance approach
• TGA statement on its approach to compliance and enforcement discretion in
the changeover to 2018 Code: https://www.tga.gov.au/therapeutic-goods-
advertising-update-29-october-2018
• Details of the TGA’s advertising complaints handling framework have been
published: https://www.tga.gov.au/publication/complaints-handling-advertising-
therapeutic-goods-australian-public
111
113. Top tips for compliant advertising
Ensure ads contain the correct mandatory statements and information with
appropriate prominence
Check advertising for complementary medicines, analgesics, vitamins,
weight loss products and sunscreens carefully to ensure full compliance
with the express provisions
Don’t use advertising with references to diseases, conditions, ailments or
defects before checking if you need restricted representation approval
112
114. Top tips for compliant advertising
Ensure testimonials, endorsements and scientific representations fully
comply with clarified requirements
Don’t use advertising that is inconsistent with the product’s ARTG entry,
directions, or instructions for use
Don’t use advertising that encourages people to delay seeking medical
advice or cease prescribed therapies
Don’t use advertising that conflicts with public health campaigns
113