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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
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.
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.
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.
The International Council for Harmonisation (ICH) is a joint regulatory-industry initiative to harmonize technical requirements for pharmaceutical product registration. It aims to reduce duplication of testing by achieving greater harmonization in guidelines' interpretation between Europe, Japan, and the United States. ICH addresses safety, quality, efficacy, and other topics through guidelines developed by expert working groups representing regulators and industry. Over two decades, ICH has successfully harmonized guidelines through scientific consensus.
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)
Regulation of cell and tissue therapies and clinical research in AustraliaTGA Australia
This document summarizes the regulation of cell and tissue therapies and clinical research in Australia. It discusses that biologicals include cell and tissue therapy products and are regulated based on their risk classification. Biologicals are grouped into four classes depending on how manipulated they are from their natural state and how closely their use matches the natural biological function. The regulatory process for including biologicals in the Australian Register of Therapeutic Goods involves evaluation of quality, safety and efficacy data by scientists and clinicians. Clinical trials of biologicals must be notified or exempted and evaluated for safety considerations. Post-market monitoring includes mandatory adverse event reporting to the Therapeutic Goods Administration.
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
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.
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
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
The document discusses the Therapeutic Goods Administration (TGA) which regulates therapeutic goods in Australia. The TGA was established in 1990 to regulate medicines, medical devices, biologicals and other therapeutic goods. It evaluates products pre-market and monitors them post-market to ensure they meet standards of quality, safety and efficacy. The TGA uses a risk-based approach to regulation, with higher risk products facing more regulatory controls like prescription-only status. It works to align Australian regulations with international guidelines from places like the EU and US.
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.
Pharmacovigilance - a regulator's perspectiveTGA Australia
The document discusses pharmacovigilance from the perspective of the Therapeutic Goods Administration (TGA) in Australia. It provides an overview of the TGA's pharmacovigilance activities, including pre-market risk management plans and post-market adverse event reporting and signal detection. It describes how the TGA monitors the safety of medicines throughout their lifecycle to identify new or unknown risks following approval.
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
Regulation of auotologous cell and tissue therapies in AustraliaTGA Australia
The document summarizes the regulation of autologous cell and tissue therapies in Australia. It discusses the current regulatory framework, public consultation on autologous stem cell therapies, and next steps. Key points include that autologous stem cell therapies are currently excluded from regulation but there are concerns about insufficient oversight and reporting of adverse events, and the consultation sought views on increasing regulatory controls over these therapies.
Presentation: Regulation of autologous cells and tissuesTGA Australia
This presentation provides an overview of the regulation of autologous cells and tissues in Australia, including a discussion on emerging examples of practices that have the potential for increased risk.
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.
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)
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.
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.
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.
The International Council for Harmonisation (ICH) is a joint regulatory-industry initiative to harmonize technical requirements for pharmaceutical product registration. It aims to reduce duplication of testing by achieving greater harmonization in guidelines' interpretation between Europe, Japan, and the United States. ICH addresses safety, quality, efficacy, and other topics through guidelines developed by expert working groups representing regulators and industry. Over two decades, ICH has successfully harmonized guidelines through scientific consensus.
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)
Regulation of cell and tissue therapies and clinical research in AustraliaTGA Australia
This document summarizes the regulation of cell and tissue therapies and clinical research in Australia. It discusses that biologicals include cell and tissue therapy products and are regulated based on their risk classification. Biologicals are grouped into four classes depending on how manipulated they are from their natural state and how closely their use matches the natural biological function. The regulatory process for including biologicals in the Australian Register of Therapeutic Goods involves evaluation of quality, safety and efficacy data by scientists and clinicians. Clinical trials of biologicals must be notified or exempted and evaluated for safety considerations. Post-market monitoring includes mandatory adverse event reporting to the Therapeutic Goods Administration.
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
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.
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
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
The document discusses the Therapeutic Goods Administration (TGA) which regulates therapeutic goods in Australia. The TGA was established in 1990 to regulate medicines, medical devices, biologicals and other therapeutic goods. It evaluates products pre-market and monitors them post-market to ensure they meet standards of quality, safety and efficacy. The TGA uses a risk-based approach to regulation, with higher risk products facing more regulatory controls like prescription-only status. It works to align Australian regulations with international guidelines from places like the EU and US.
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.
Pharmacovigilance - a regulator's perspectiveTGA Australia
The document discusses pharmacovigilance from the perspective of the Therapeutic Goods Administration (TGA) in Australia. It provides an overview of the TGA's pharmacovigilance activities, including pre-market risk management plans and post-market adverse event reporting and signal detection. It describes how the TGA monitors the safety of medicines throughout their lifecycle to identify new or unknown risks following approval.
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
Regulation of auotologous cell and tissue therapies in AustraliaTGA Australia
The document summarizes the regulation of autologous cell and tissue therapies in Australia. It discusses the current regulatory framework, public consultation on autologous stem cell therapies, and next steps. Key points include that autologous stem cell therapies are currently excluded from regulation but there are concerns about insufficient oversight and reporting of adverse events, and the consultation sought views on increasing regulatory controls over these therapies.
Presentation: Regulation of autologous cells and tissuesTGA Australia
This presentation provides an overview of the regulation of autologous cells and tissues in Australia, including a discussion on emerging examples of practices that have the potential for increased risk.
TGA Presentation: Biologicals framework updatesTGA Australia
The document summarizes recent changes and proposed updates to Australia's regulatory framework for biological products such as human cells and tissues (biologicals). Key points:
- The biologicals framework regulates cell and tissue therapies and was introduced in 2011. It applies different regulation levels based on product risks.
- Recent approvals include various tissue-based products and cell therapies. Challenges include improving product characterization and developing potency assays.
- Proposed changes include updating guidance documents, expanding expedited pathways similar to the US and EU, and allowing some autologous cell/tissue uses to be exempt from regulation.
- The review aims to facilitate earlier patient access to innovative therapies while maintaining safety, efficacy and
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
Good Regulatory Practices (GRP) are internationally recognized processes, systems, tools and methods for improving the quality of regulations. GRP systematically implements public consultation and stakeholder engagement as well as impact analysis of government proposals before implementation to ensure they are fit for purpose. The document discusses various aspects of pharmaceutical regulations in India including licensing, e-governance of regulatory authorities, import/export guidelines, clinical trial requirements, and roles of community pharmacies, hospital pharmacies, and pharmaceutical manufacturing/wholesale business.
Stem cells now and in the future: regulation in AustraliaTGA Australia
This presentation provides an insight into the current use of stem cells in research and in the clinic, while discussing technical, regulatory and policy implications.
Presentation: Regulatory affairs - The Australian and International landscapeTGA Australia
With local regulatory reforms and reactions to critical global events manifesting in more regulatory shifts, it has been hard to keep up with progress lately. This session provides an opportunity to hear directly from key regulators about their thoughts on the current and future regulatory environment and how it is evolving in response to these global shifts and the multitude of other challenges faced by regulators.
Medicines and Medical Devices Regulation – current developments and future op...TGA Australia
1. The document summarizes recent developments and future options in medicines and medical devices regulation in Australia, as presented by John Skerritt from the Department of Health.
2. Key updates included planned changes to medicines labeling, reviews of programs for orphan drugs and recalls, and a new online system for clinical trial notifications.
3. The presentation also discussed an expert panel review that recommended modernizing approval pathways for new drugs and generics, adopting risk-based approaches, and reforms to schemes for unapproved products.
This document discusses the duties and responsibilities of optometrists regarding drug use and supply. It outlines the different drug names including chemical, generic, and brand names. It describes exemptions that allow optometrists to access certain prescription-only medicines and legislative changes that expanded what drugs optometrists can prescribe and supply directly. The document also provides guidance on proper use, storage, disposal and adverse reaction reporting of drugs in optometric practice.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
TGA presentation: Update on recent activitiesTGA Australia
This document provides an update on recent activities and ongoing reforms from the Scientific Evaluation Branch of the Therapeutic Goods Administration of Australia. It discusses implemented reforms such as streamlined variations for prescription medicines, utilizing evaluation reports from comparable overseas regulators, and biological and biosimilar medicines naming. Upcoming reforms addressed include improved labeling of neuromuscular blocking agents and regulation of fecal microbiota transplantation material. Approval times for different categories of medicines over the past years are also presented.
This document summarizes the current regulatory challenges for conducting clinical trials in India. It outlines the evolution of India's clinical trial regulatory framework over time in response to incidents of malpractice. Key recommendations from an expert committee include accrediting clinical sites and investigators, establishing expert review committees, and providing compensation for injuries from trials. Regulatory actions by Indian authorities aim to implement these recommendations. The pharmaceutical industry desires further clarity on issues like liability and access to drugs post-trials. Overall improvements are expected in areas like accreditation, compensation policies, and transparency of the regulatory system.
Reforms to the regulatory framework for listed medicinesTGA Australia
The document summarizes reforms to Australia's regulatory framework for listed medicines. It discusses reforms that have already been implemented, such as shorter evaluation timeframes and market exclusivity for new ingredients. Reforms still being developed include using reports from comparable overseas regulators and allowing an "efficacy assessment claimer" on certain products. Future reforms involve strengthening post-market monitoring and providing more guidance for sponsors. The document also explains the three pathways for listed medicines: AUST L, AUST L(A) which allows pre-market efficacy evaluation, and AUST R for registered medicines.
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
35 Tips to help you Pass the 2020 PTCB ExamRxTechExam
The document provides tips for preparing for the 2020 PTCB exam, including learning the top 200 drugs by generic and brand name, understanding therapeutic equivalents and drug interactions, ensuring proper handling of hazardous substances and compliance with legal requirements like those of the DEA. It also covers sterile and non-sterile compounding processes and guidelines, medication error prevention, and situations that require pharmacist intervention like DUR alerts and adverse drug events.
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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.
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
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.
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.
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.
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
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.
The biomechanics of running involves the study of the mechanical principles underlying running movements. It includes the analysis of the running gait cycle, which consists of the stance phase (foot contact to push-off) and the swing phase (foot lift-off to next contact). Key aspects include kinematics (joint angles and movements, stride length and frequency) and kinetics (forces involved in running, including ground reaction and muscle forces). Understanding these factors helps in improving running performance, optimizing technique, and preventing injuries.
Are you looking for a long-lasting solution to your missing tooth?
Dental implants are the most common type of method for replacing the missing tooth. Unlike dentures or bridges, implants are surgically placed in the jawbone. In layman’s terms, a dental implant is similar to the natural root of the tooth. It offers a stable foundation for the artificial tooth giving it the look, feel, and function similar to the natural tooth.
Breast cancer: Post menopausal endocrine therapyDr. Sumit KUMAR
Breast cancer in postmenopausal women with hormone receptor-positive (HR+) status is a common and complex condition that necessitates a multifaceted approach to management. HR+ breast cancer means that the cancer cells grow in response to hormones such as estrogen and progesterone. This subtype is prevalent among postmenopausal women and typically exhibits a more indolent course compared to other forms of breast cancer, which allows for a variety of treatment options.
Diagnosis and Staging
The diagnosis of HR+ breast cancer begins with clinical evaluation, imaging, and biopsy. Imaging modalities such as mammography, ultrasound, and MRI help in assessing the extent of the disease. Histopathological examination and immunohistochemical staining of the biopsy sample confirm the diagnosis and hormone receptor status by identifying the presence of estrogen receptors (ER) and progesterone receptors (PR) on the tumor cells.
Staging involves determining the size of the tumor (T), the involvement of regional lymph nodes (N), and the presence of distant metastasis (M). The American Joint Committee on Cancer (AJCC) staging system is commonly used. Accurate staging is critical as it guides treatment decisions.
Treatment Options
Endocrine Therapy
Endocrine therapy is the cornerstone of treatment for HR+ breast cancer in postmenopausal women. The primary goal is to reduce the levels of estrogen or block its effects on cancer cells. Commonly used agents include:
Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
Selective Estrogen Receptor Downregulators (SERDs): Fulvestrant is a SERD that degrades estrogen receptors and is used in cases where resistance to other endocrine therapies develops.
Combination Therapies
Combining endocrine therapy with other treatments enhances efficacy. Examples include:
Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
Endocrine Therapy with mTOR Inhibitors: Everolimus, an mTOR inhibitor, can be added to endocrine therapy for patients who have developed resistance to aromatase inhibitors.
Chemotherapy
Chemotherapy is generally reserved for patients with high-risk features, such as large tumor size, high-grade histology, or extensive lymph node involvement. Regimens often include anthracyclines and taxanes.
STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS E7shruti jagirdar
Unit 4: MRA 103T Regulatory affairs
This guideline is directed principally toward new Molecular Entities that are
likely to have significant use in the elderly, either because the disease intended
to be treated is characteristically a disease of aging ( e.g., Alzheimer's disease) or
because the population to be treated is known to include substantial numbers of
geriatric patients (e.g., hypertension).
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Changes to the regulation of autologous cells and tissues
1. Changes to the regulation of autologous cells and tissues
Dr Ian Prosser
Senior Medical Advisor
Therapeutic Goods Administration
June 2018
2. Overview
• Background
• Changes to regulation of autologous cells & tissues (HCT)
• Subject to approval commence 1 July 2018
• Transition provisions
• Excluded from TGA regulation
• Exempt from certain regulatory requirements
• Regulated as a biological
• Minimal manipulation and homologous use
• Examples: Platelet-rich plasma (PrP), Stromal vascular
fraction (SVF)
• Implementation
• Questions
3. Some regulators of products & practices
• Regulated by TGA
• Therapeutic Goods Act 1989
Therapeutic use/ clinical trial products in
humans
• Regulated by Food Standards Australia New Zealand
• Australia New Zealand Food Standards CodeFood
• Research process regulated by the National Health and Medical Research Council
• Australian Code for the Responsible Conduct in Research
• Australian Health Ethics Committee
Research (potential therapeutic) products
• Regulated by Pharmacy Board of Australia
• Guidelines on the Compounding of Medicines by the Pharmacy Board of Australia
Single patient compounded
pharmaceuticals
• Regulated by Australian Pesticides & Veterinary Medicines Authority
• Agricultural and Veterinary Chemicals Act 1994Veterinary medicines
• Regulated under then National Industrial Chemicals Notification and Assessment Scheme
• Industrial Chemical (Notification and Assessment) Act 1989Cosmetics & industrial chemicals
• Regulated by Medical Board of Australia/Australian Health Practitioner Regulatory Agency
• Health Practitioner Regulation National Law, National Registration and Accreditation SchemeMedical practice derived products 2
4. Autologous human cells & tissues
• Human cell and tissue (HCT)
products are those that comprise,
contain or are derived from human
cells and tissues.
• Autologous human cell and tissue
(HCT) products are those that are
removed from, and applied to, the
same person, i.e. the donor and the
recipient are the same.
• These include some products
commonly referred to as 'stem cell
treatments'.
• skin grafts for treatment of burns
• bone grafts
• bone marrow transplants
• conditioned serum
• genetically-altered lymphocytes to target cancers
• bone marrow-derived stem cells for non-
haematological indications
• adipose-derived cell extracts (including stromal
vascular fraction (SVF))
• blood and blood components (red cells, plasma,
serum, platelets, and platelet-rich plasma (PrP))
3
5. Current Therapeutic Goods (Excluded Goods) Order No. 1
of 2011 (EGO)
• Autologous cells and tissues (Medical practice)
– collected under the care of a medical practitioner, and
– manufactured for treatment of a single indication, and
– in a single course of treatment of that patient by the same
medical practitioner, or by a person under their supervision
– Other autologous uses are not exempt in Australia
• Position reviewed in response to concerns
4
6. Review of current Excluded Goods Order
• Concerns raised with current Order
• Advertising claims for unproven therapies
• Scope of exclusion not internationally aligned
• Scope of activity and complexity of products has changed since
2011; increasing safety concerns
• Broad public consultation on options in 2015 and 2016
• Government agreement to an option supported by the majority of
stakeholders
5
7. Changes to regulation of autologous cells & tissues
– Increase the level of oversight by TGA of autologous HCT
– Three levels of regulation of autologous HCT
• Excluded from TGA regulation
• Exempt from certain regulatory requirements
• Regulated as a biological
• Aligns more closely with international practice
• Some changes come in to effect from 1 July 2018; other changes will be
subject to transition provisions
6
8. Changes in place from 1 July 2018
Applies to all autologous HCT products:
– No direct advertising to consumers of autologous cell and tissue products
from 1 July 2018 (Jenny Mason)
The following conditions also apply to Exempt and Fully Regulated products:
– Reporting of adverse events to TGA
– Compliance with all applicable standards
Donor screening and testing (Therapeutic Goods Order 88)
7
9. Transition provisions
• When autologous HCT products have been supplied before 1 July 2018
supply may continue until 30 June 2019
• Further transition provisions
• Exemption from GMP requirements where an application is received to
seek GMP certification before 30 June 2019
• Where a full market authorisation or a CTX application is made and
accepted for evaluation by 30 June 2019
• Supply can continue under the provision until a decision is made on the
application
8
10. Changes to regulation of autologous cells & tissues
Excluded from TGA regulation
Exclude from regulation by the TGA only those autologous cell and tissue
products that are manufactured and used in an accredited hospital
• the goods were collected and manufactured by, or under the professional
supervision of, the practitioner in an accredited hospital
• For use in that patient by that practitioner or persons under their supervision
• the goods are not advertised or promoted directly to consumers;
– Designed to exclude certain autologous cells and tissues that are associated
with established medical practice
– Accredited hospitals are responsible for decisions on the appropriateness of
procedures and products manufactured in their institution
– For example, vascular conduits, skull flaps, cultured keratinocytes and
hematopoietic progenitor cells for reconstitution of blood after chemotherapy
9
11. Changes to regulation of autologous cells & tissues
Excluded from TGA regulation – Hospital accreditation
• Public and private hospitals in Australia are subject to regulation under
various state, territory and national provisions
• Credentialing processes are applied by hospitals to ensure that
practitioners do not work outside of their scope of practice
• Hospitals are accredited to the National Safety and Quality Health Service
(NSQHS) Standards
• Hospitals should have governance and procedures in place to ensure
manufacturing and use of autologous HCT is appropriate
10
12. Changes to regulation of autologous cells & tissues
Excluded from TGA regulation – Manufacturing
• Collection and manufacturing must occur within the hospital and under the
professional supervision of the medical practitioner
• Professional supervision requires that the medical/dental practitioner with
primary responsibility for the clinical care of a patient is party to all
manufacturing steps that are performed through a formal arrangement with
the person or persons undertaking the manufacturing.
Specialised testing on a representative sample of the product by a third-
party facility, for example sterility testing.
Offsite or third-party manufacturing of the product
11
13. Changes to regulation of autologous cells & tissues
Exempt from certain regulatory requirements
Regulation under Biologicals Regulatory framework with exemptions
from some requirements for autologous HCT that are:
minimally manipulated, and
for homologous use only, and
manufactured and used outside a hospital by a medical or dental
practitioner,
for a patient in the same practitioner’s care.
• Conditions set to limit this option to only low risk products, where there
is still a high level of clinical oversight by the practitioner.
• Exempt from being on the Register (no market authorisation), and GMP
12
14. Changes to regulation of autologous cells & tissues
Exempt from certain regulatory requirements – continued
• No advertising to consumers
• Single indication/single procedure
• Any treatment that involves more than a single procedure may significantly
increase the risks to safety associated with traceability, sterility and quality of
the product
• Treatments involving storage of the HCT do not fall within the scope of the
exemption provisions.
• The primary indication for the autologous HCT product in any procedure or
treatment should be clearly documented
• Guidance on what meets the definitions of minimal manipulation and
homologous use
• Standards, advertising restrictions, and adverse event reporting will
apply. Enforcement options will include the ability for TGA to request
information and take appropriate action. 13
15. Minimal manipulation
The goods have been subjected to minimal manipulation if no process or
processes to which the goods have been subjected have altered any of the
biological characteristics, physiological functions or structural properties of the
original cells or tissues that are relevant to the purpose for which the manufacturer
of the goods intends the goods to be used
• Introduces a link between the processes to which the cells and tissue are subject and
the intended clinical function of the product, which is crucial for assigning an
appropriate risk classification
• Removes definitional issues around the previous list of actions
• Designed to draw a line between medical practice and product manufacturing
• Not all functions may be preserved during processing, but the manufacturer must be
able to show that the activity of relevant characteristics related to the intended use is
sufficiently maintained. This may require a reasonable understanding of the
mechanism(s) of action.
14
16. Homologous use
Homologous use of the goods is use of the goods to repair, reconstruct, replace
or supplement the cells or tissues of a person (the recipient), if the goods will
perform the same basic function or functions in the recipient as the original cells
or tissues performed in the person from whom they were collected.
• Where this definition is not met, compared with a homologous use, there would be
increased safety and efficacy concerns with the use of the HCT as there is less
information on which to predict the behaviour of the product.
• In determining whether the use of the HCT is homologous, the intended clinical
treatment will be carefully considered, including review of the manufacturer’s labelling
and advertising material.
15
17. Exempt from certain regulatory requirements – Example
• Platelet-rich plasma:
• Preparation of platelet-rich plasma from a single uninterrupted venipuncture, for injection in to damaged
tissue. Generally the processing involved does not alter the functions of the platelets so is considered
minimal manipulation.
• The mechanism of platelet–rich plasma action in the treatment of musculoskeletal disorders remains to be
determined and evaluation of platelet–rich plasma in clinical trials is incomplete. The basic functions that
would apply to platelet-rich plasma are based on the understanding of the normal healing process of
musculoskeletal tissue. The repair response of musculoskeletal tissues starts with the formation of a blood
clot and degranulation of platelets. This degranulation of platelets releases a range of growth factors and
cytokines into the local environment that trigger a cascade of events that lead to healing of the wound. Where
it can be demonstrated or justified that the intended use of PrP can augment or stimulate healing by turning
on the same repair response it could be considered to be a homologous use.
16
18. Exempt from certain regulatory requirements – Example
• Platelet-rich plasma:
– The intended clinical use of PrP under these exemptions still needs to be justified based on proven
evidence of safety and efficacy
– PrP product would likely be considered a blood component (and regulated as a medicine), being prepared
only by centrifugation, and filtration
– The exemptions only apply when the PrP is manufactured and administered by or under the supervision of
a registered medical practitioner for a patient under their care and do not apply to other health practitioners
– Where equipment (such as a commercial kit) is used in the manufacture of PrP or conditioned serum it
may also be subject to regulation as a medical device
– Cosmetic use of injected PrP is likely to be regulated by TGA where therapeutic claims are made or
inferred. Generally, injectable products fall under the Australian legal definition for therapeutic use (for
example, as they are intended to cure a defect or modify the anatomy, even if it is only for 'aesthetic'
purposes).
17
19. Changes to regulation of autologous cells & tissues
Regulated as a biological
Regulate under the Biologicals Regulatory Framework those autologous
human cell and tissue products that are:
manufactured and used outside an accredited hospital, and
more than minimally manipulated, or
for non-homologous use.
– Products may still be accessed through clinical trials or
compassionate use schemes
– Market authorisation and GMP requirements apply.
18
20. Regulated as a biological - Example
Adipose tissue example:
a. A manufacturer processes adipose tissue (enzymatic or physical dissociation) with
the aim to dissociate cell-cell contacts and isolate the cellular portion. The resultant
product (such as stromal vascular fraction (SVF)) is injected back in to patients for
reputed anti-inflammatory uses. In this case the cells responsible for the intended use
and to which the determination of minimal manipulation applies (e.g. mesenchymal
stem cells) would be considered the autologous HCT product. Such methods used to
disrupt adipose tissue would be considered beyond minimal manipulation. The
process applied to isolate the cells is likely to result in changes to their properties, e.g.
activation state or surface molecule expression, which could significantly impact the
cells characteristics or functions.
19
21. Regulated as a biological - Example
• Adipose tissue may be collected and then reinjected with minimal manipulation, or
may be subjected to processing to extract the cellular portion from the tissue.
• The HCT extracted from adipose includes various cellular fractions (of varying purity),
and are collectively referred to as Stromal Vascular Fraction (SVF).
• Homologous uses include:
– providing cushioning and support for other tissues, including the skin and internal
organs
– storing energy in the form of lipids, and
– insulating the body.
• Where the HCT provided to the recipient is a cell extract, the determination of
homologous use would make reference to the basic functions of the cells located in
the adipose, rather than those of the tissue collectively.
• SVF isolated from adipose tissue is used to treat musculoskeletal conditions, such as
arthritis or tendonitis by regenerating or promoting the regeneration of articular
cartilage or tendon. This application is considered a non-homologous use.
20
22. Implementation
• Staged implementation – advertising restriction, transition
• In the first instance, we seek to inform, educate and assist
stakeholders
• Communication strategy over next 12 months to target different
stakeholder groups, including consumer groups
• Teleconferences and face-to-face meeting options
• Submitted questions after the Advertising presentation
• Primary contact for further enquiries is bloodandtissues@tga.gov.au
• Link to current guidance: Biologicals regulatory framework proposed
changes to start on 1 July 2018 (www.tga.gov.au/publication/biologicals-
regulatory-framework-proposed-changes-start-1-july-2018)
21
23. Advertising Unapproved HCT Therapies
• Unapproved autologous HCT products which are regulated as
exempt biologicals from 1 July 2018 will be prohibited from being
advertised to consumers under the Therapeutic Goods Act 1989
(the Act).
• Likewise, autologous HCT products which are proposed to be
excluded from the operation of the Act from 1 July 2018 may not be
advertised to consumers.
22
24. Making claims to arrange supply of unapproved
HCT therapies
• Making claims to arrange supply of unapproved HCT therapies (as distinct
from advertising) is also prohibited under the Act unless :
– Those goods are subject to an exemption, approval or authority under
one of a number of different schemes included in the Act.
– The claim is limited to the terms of that exemption/ approval; and
– communicated between the relevant parties to that exemption, approval
or authority
• This means that claims to arrange supply of unapproved HCT therapies
cannot be broadly made to consumers or health professionals.
23
25. Education / guidance
• New “Advertising hub” planned for website
– Easier to locate from homepage
– Access to education, guidance, complaint form, inquiry form etc
• Three e-learning modules under development
• Australian Regulatory Guidelines on Advertising Therapeutic Goods
• Consumer-specific materials:
– Fact sheets – lodging complaints, identifying non-compliant ads
– Short video on advertising requirements
24