Therapeutics Goods Administration(TGA) is a unit of the Australian Government Department of Health and Ageing, is responsible for administering the act.
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
The Hatch-Waxman Act established an abbreviated approval pathway for generic drugs that relies on the safety and efficacy evidence of the branded reference drug. It aims to balance incentives for innovation and generic competition. The Act created ANDAs that allow generics to enter the market after patents and exclusivities expire. It also provides the branded drug up to 30 months to litigate patents against Paragraph IV ANDA challenges and restores some patent term lost during regulatory review.
This document provides an introduction and overview of the Orange Book, formally known as "Approved Drug Products with Therapeutic Equivalence Evaluations". The Orange Book is published by the FDA and lists approved drug products and determines whether generic drugs are equivalent to brand name drugs. It identifies drug products approved by the FDA, determines therapeutic equivalence of generic drugs, and provides patent and exclusivity information to facilitate generic drug approval. The document outlines the history, contents, and objectives of the Orange Book in facilitating review of drug use and substitution of equivalent generic drugs.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
The Hatch-Waxman Act established an abbreviated approval pathway for generic drugs that relies on the safety and efficacy evidence of the branded reference drug. It aims to balance incentives for innovation and generic competition. The Act created ANDAs that allow generics to enter the market after patents and exclusivities expire. It also provides the branded drug up to 30 months to litigate patents against Paragraph IV ANDA challenges and restores some patent term lost during regulatory review.
This document provides an introduction and overview of the Orange Book, formally known as "Approved Drug Products with Therapeutic Equivalence Evaluations". The Orange Book is published by the FDA and lists approved drug products and determines whether generic drugs are equivalent to brand name drugs. It identifies drug products approved by the FDA, determines therapeutic equivalence of generic drugs, and provides patent and exclusivity information to facilitate generic drug approval. The document outlines the history, contents, and objectives of the Orange Book in facilitating review of drug use and substitution of equivalent generic drugs.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia.he TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
Regulatory requirements for new drug approval are in place to ensure medications are safe and effective for consumers. Regulatory affairs evaluate drug development, production, and marketing. Key functions include monitoring legislation changes and ensuring manufacturing and marketing practices comply with regulations. Stringent approval processes were implemented after tragic incidents revealed drug safety issues. Notable regulatory bodies include the FDA in the US and CDSCO in India. Approval involves non-clinical and clinical trials to assess safety, efficacy, and quality before marketing applications like an NDA can be submitted for review. Compliance with regulatory standards is necessary throughout the drug development and approval process.
The Common Technical Document (CTD) is a standardized format for new drug applications agreed upon by international regulatory agencies. It has 5 modules covering administrative information, summaries, quality, non-clinical studies, and clinical studies. The electronic CTD (eCTD) is the electronic version that regulatory agencies now require. eCTD submissions have granular documents linked by XML and allow for increased transparency, ease of review, and benefits like reduced submission time and costs.
The document provides an overview of the Orange Book, which is a publication by the FDA that lists approved drug products with therapeutic equivalence evaluations. It discusses the history, contents, and purpose of the Orange Book. The key points covered include a description of the drug approval process, how generic drugs are evaluated for therapeutic equivalence, and how the Orange Book is organized to list brand and generic drug products along with their therapeutic equivalence ratings.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Regulatory requirement of EU, MHRA and TGAHimal Barakoti
The document summarizes regulatory requirements for medicines in the European Union, United Kingdom, Australia, and other countries. The European Medicines Agency regulates medicines for the EU and ensures they are safe, effective and high quality. Medicines must receive market authorization from the EMA or national authorities before sale. The UK's Medicines and Healthcare Products Regulatory Agency regulates clinical trials and product licensing. Australia's Therapeutic Goods Administration ensures medicines available there meet quality, safety and efficacy standards.
This document provides an overview of Vineeth Kumar Ekbote's lab presentation on new drug applications (NDAs). The presentation covers what an NDA is, the goals and process of an NDA, the forms and contents required in an NDA submission, guidance documents for NDAs, and how NDAs are reviewed and approved by the FDA. The presentation also describes the various sections required in an NDA, including the application summary, chemistry and manufacturing controls, clinical data, and labeling.
This document provides a summary of a presentation on generic drugs. It discusses the definition of generic drugs, the generic drug development and approval process, provisions of the Hatch-Waxman Act, and relevant sections of the Code of Federal Regulations. The summary highlights that a generic drug must be equivalent to the branded version in ingredients, dosage, safety and efficacy. It also outlines the steps in generic drug approval via an Abbreviated New Drug Application, including requirements for bioequivalence testing and patent certifications. Additionally, it notes provisions established by the Hatch-Waxman Act related to patent term extensions and patent challenges involved in the generic approval pathway.
The document discusses clinical trials and good clinical practice (GCP) guidelines. It provides definitions and explanations of key concepts.
Specifically, it defines a clinical trial as an investigation in human subjects to discover or verify the effects of an investigational product. It describes GCP as international standards for clinical trial conduct that ensure data credibility and protect subject rights. The guidelines aim to harmonize standards across regions through organizations like the International Council for Harmonization.
The document then outlines investigator responsibilities in areas like trial preparation, conduct, and closure to ensure compliance with GCP standards and protect subject safety and data integrity.
This document provides an overview of the new drug application (NDA) process for obtaining approval to market a new pharmaceutical drug in the United States. It describes the history of NDAs, the application requirements, FDA review process, possible outcomes, and an example of a drug that was initially not approved but later was approved after further use and review in other countries. The overall purpose of the NDA process is to ensure new drugs meet standards of safety and effectiveness before being approved for use and sale.
The document provides an overview of the requirements and guidelines for generic drug dossiers using the ASEAN Common Technical Document (ACTD) format. It describes the organization of the ACTD, which contains four parts covering administrative data, quality documents, nonclinical documents, and clinical documents. Part I includes the table of contents, administrative information, and product information. Part II focuses on quality documents for the drug substance and product. Parts III and IV are generally not applicable for generic drugs. The document also lists the types of documents required to complete each part of the ACTD for a generic drug application.
The document discusses India's drug regulatory system. The Drug Controller General of India regulates drugs and medical devices in the country to ensure quality, safety and efficacy. New drugs require approval through a New Drug Application process which involves submitting documentation on manufacturing, non-clinical studies, and clinical trials for review. It takes about a year to review an NDA and various forms and fees are involved in the approval and import license application processes.
Pharmacovigilance safety Mon. in clinical trials.pptxRoshan Yadav
Pharmacovigilance involves monitoring drug safety and adverse effects during clinical trials. Safety monitoring is critical and requires collaboration between stakeholders like sponsors, investigators, ethics committees, and regulators. Common safety monitoring practices include sponsors developing protocols detailing reporting procedures, investigators collecting data in case report forms, and ethics committees and data safety monitoring boards regularly reviewing accumulating trial data to protect participants.
REGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICESArunpandiyan59
This document provides an overview of regulations for combination products and medical devices in the United States and India. It discusses what combination products are, examples of combination products, and the roles of the US FDA Office of Combination Products in classifying and assigning combination products for review. It also summarizes the regulatory requirements for medical devices in the US, including establishment registration, medical device listing, premarket notification, premarket approval, and quality system regulations. The latest developments in medical device regulation in India are also briefly outlined.
- Generic drugs are comparable to brand name drugs in dosage, quality, and intended use but are cheaper. They contain the same active ingredients as original formulations.
- The generic drug development process involves concept development, system-level design, detail design, testing and refinement, production ramp-up, and product launch. It aims to develop affordable drugs that balance public health needs.
- Generic drugs are available after patents or marketing rights expire on brand name drugs. They maintain quality at affordable prices for critical diseases.
The FDA is the government agency responsible for regulating food, drugs, medical devices, and other products in the United States. It has headquarters in Maryland and over 200 field offices across the country. The FDA regulates items like foods, drugs, medical devices, vaccines, and more to ensure they are safe and properly labeled. It is made up of centers that focus on specific product areas like drugs, devices, food, tobacco, and more. The document provides details on the FDA's structure, responsibilities, processes, and international collaboration efforts.
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 Food and Drug Administration (FDA) is organized into 8 centers that regulate specific products and conduct research. The centers are:
1. The Center for Biologics Evaluation and Research regulates vaccines, blood, and gene therapies.
2. The Center for Devices and Radiological Health oversees medical devices and radiation-emitting products.
3. The Center for Drug Evaluation and Research regulates prescription and over-the-counter drugs.
4. The Center for Food Safety and Applied Nutrition regulates food, dietary supplements, bottled water and cosmetics.
5. The Center for Tobacco Products regulates cigarettes and smokeless tobacco.
6. The Center for Veterinary Medicine regulates
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia.he TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
Regulatory requirements for new drug approval are in place to ensure medications are safe and effective for consumers. Regulatory affairs evaluate drug development, production, and marketing. Key functions include monitoring legislation changes and ensuring manufacturing and marketing practices comply with regulations. Stringent approval processes were implemented after tragic incidents revealed drug safety issues. Notable regulatory bodies include the FDA in the US and CDSCO in India. Approval involves non-clinical and clinical trials to assess safety, efficacy, and quality before marketing applications like an NDA can be submitted for review. Compliance with regulatory standards is necessary throughout the drug development and approval process.
The Common Technical Document (CTD) is a standardized format for new drug applications agreed upon by international regulatory agencies. It has 5 modules covering administrative information, summaries, quality, non-clinical studies, and clinical studies. The electronic CTD (eCTD) is the electronic version that regulatory agencies now require. eCTD submissions have granular documents linked by XML and allow for increased transparency, ease of review, and benefits like reduced submission time and costs.
The document provides an overview of the Orange Book, which is a publication by the FDA that lists approved drug products with therapeutic equivalence evaluations. It discusses the history, contents, and purpose of the Orange Book. The key points covered include a description of the drug approval process, how generic drugs are evaluated for therapeutic equivalence, and how the Orange Book is organized to list brand and generic drug products along with their therapeutic equivalence ratings.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Regulatory requirement of EU, MHRA and TGAHimal Barakoti
The document summarizes regulatory requirements for medicines in the European Union, United Kingdom, Australia, and other countries. The European Medicines Agency regulates medicines for the EU and ensures they are safe, effective and high quality. Medicines must receive market authorization from the EMA or national authorities before sale. The UK's Medicines and Healthcare Products Regulatory Agency regulates clinical trials and product licensing. Australia's Therapeutic Goods Administration ensures medicines available there meet quality, safety and efficacy standards.
This document provides an overview of Vineeth Kumar Ekbote's lab presentation on new drug applications (NDAs). The presentation covers what an NDA is, the goals and process of an NDA, the forms and contents required in an NDA submission, guidance documents for NDAs, and how NDAs are reviewed and approved by the FDA. The presentation also describes the various sections required in an NDA, including the application summary, chemistry and manufacturing controls, clinical data, and labeling.
This document provides a summary of a presentation on generic drugs. It discusses the definition of generic drugs, the generic drug development and approval process, provisions of the Hatch-Waxman Act, and relevant sections of the Code of Federal Regulations. The summary highlights that a generic drug must be equivalent to the branded version in ingredients, dosage, safety and efficacy. It also outlines the steps in generic drug approval via an Abbreviated New Drug Application, including requirements for bioequivalence testing and patent certifications. Additionally, it notes provisions established by the Hatch-Waxman Act related to patent term extensions and patent challenges involved in the generic approval pathway.
The document discusses clinical trials and good clinical practice (GCP) guidelines. It provides definitions and explanations of key concepts.
Specifically, it defines a clinical trial as an investigation in human subjects to discover or verify the effects of an investigational product. It describes GCP as international standards for clinical trial conduct that ensure data credibility and protect subject rights. The guidelines aim to harmonize standards across regions through organizations like the International Council for Harmonization.
The document then outlines investigator responsibilities in areas like trial preparation, conduct, and closure to ensure compliance with GCP standards and protect subject safety and data integrity.
This document provides an overview of the new drug application (NDA) process for obtaining approval to market a new pharmaceutical drug in the United States. It describes the history of NDAs, the application requirements, FDA review process, possible outcomes, and an example of a drug that was initially not approved but later was approved after further use and review in other countries. The overall purpose of the NDA process is to ensure new drugs meet standards of safety and effectiveness before being approved for use and sale.
The document provides an overview of the requirements and guidelines for generic drug dossiers using the ASEAN Common Technical Document (ACTD) format. It describes the organization of the ACTD, which contains four parts covering administrative data, quality documents, nonclinical documents, and clinical documents. Part I includes the table of contents, administrative information, and product information. Part II focuses on quality documents for the drug substance and product. Parts III and IV are generally not applicable for generic drugs. The document also lists the types of documents required to complete each part of the ACTD for a generic drug application.
The document discusses India's drug regulatory system. The Drug Controller General of India regulates drugs and medical devices in the country to ensure quality, safety and efficacy. New drugs require approval through a New Drug Application process which involves submitting documentation on manufacturing, non-clinical studies, and clinical trials for review. It takes about a year to review an NDA and various forms and fees are involved in the approval and import license application processes.
Pharmacovigilance safety Mon. in clinical trials.pptxRoshan Yadav
Pharmacovigilance involves monitoring drug safety and adverse effects during clinical trials. Safety monitoring is critical and requires collaboration between stakeholders like sponsors, investigators, ethics committees, and regulators. Common safety monitoring practices include sponsors developing protocols detailing reporting procedures, investigators collecting data in case report forms, and ethics committees and data safety monitoring boards regularly reviewing accumulating trial data to protect participants.
REGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICESArunpandiyan59
This document provides an overview of regulations for combination products and medical devices in the United States and India. It discusses what combination products are, examples of combination products, and the roles of the US FDA Office of Combination Products in classifying and assigning combination products for review. It also summarizes the regulatory requirements for medical devices in the US, including establishment registration, medical device listing, premarket notification, premarket approval, and quality system regulations. The latest developments in medical device regulation in India are also briefly outlined.
- Generic drugs are comparable to brand name drugs in dosage, quality, and intended use but are cheaper. They contain the same active ingredients as original formulations.
- The generic drug development process involves concept development, system-level design, detail design, testing and refinement, production ramp-up, and product launch. It aims to develop affordable drugs that balance public health needs.
- Generic drugs are available after patents or marketing rights expire on brand name drugs. They maintain quality at affordable prices for critical diseases.
The FDA is the government agency responsible for regulating food, drugs, medical devices, and other products in the United States. It has headquarters in Maryland and over 200 field offices across the country. The FDA regulates items like foods, drugs, medical devices, vaccines, and more to ensure they are safe and properly labeled. It is made up of centers that focus on specific product areas like drugs, devices, food, tobacco, and more. The document provides details on the FDA's structure, responsibilities, processes, and international collaboration efforts.
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 Food and Drug Administration (FDA) is organized into 8 centers that regulate specific products and conduct research. The centers are:
1. The Center for Biologics Evaluation and Research regulates vaccines, blood, and gene therapies.
2. The Center for Devices and Radiological Health oversees medical devices and radiation-emitting products.
3. The Center for Drug Evaluation and Research regulates prescription and over-the-counter drugs.
4. The Center for Food Safety and Applied Nutrition regulates food, dietary supplements, bottled water and cosmetics.
5. The Center for Tobacco Products regulates cigarettes and smokeless tobacco.
6. The Center for Veterinary Medicine regulates
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.
The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia to protect public health and safety. It evaluates medicines and medical devices to ensure they are safe, effective and of high quality before being supplied in Australia. The TGA is part of the Australian Government Department of Health and has approximately 750 staff from various scientific, medical and administrative backgrounds. It undertakes pre-market evaluations, licenses manufacturers, monitors the market post-approval and maintains the Australian Register of Therapeutic Goods which lists all approved medicines and devices. Higher risk products undergo a rigorous approval process while lower risk goods follow a streamlined listing process.
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.
The document discusses pharmacovigilance in Australia. It notes that Australia spends over $121 billion annually on health care, accounting for 9.4% of total economic spending. The Therapeutic Goods Administration regulates medicines and vaccines in Australia. Adverse drug reactions are monitored through spontaneous reporting to the Australian Adverse Drug Reactions Advisory Committee, which medical experts review. Over 10,000 reports are received annually, mostly involving prescription medicines. Pharmacovigilance guidelines provide requirements for risk management plans and adverse event reporting. Education initiatives aim to increase reporting by health professionals.
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.
The regulatory guidelines of Australia provide a comprehensive framework for regulating therapeutic goods including medicines. Key aspects of the framework include:
1. Therapeutic goods are classified as either registered or listed medicines depending on their risk level. Registered medicines undergo more rigorous assessment of safety, quality and efficacy.
2. The main legislation is the Therapeutic Goods Act of 1989, which establishes national controls for medicines. Other regulations and committees provide supportive governance.
3. For approval, medicines must be listed or registered on the Australian Register of Therapeutic Goods through a pre-market assessment of safety, quality and sometimes efficacy. Extensive evaluation and oversight is provided by the Therapeutic Goods Administration and its committees.
The US Food and Drug Administration (FDA) regulates food, drugs, medical devices, cosmetics and radiation-emitting products. It aims to protect public health by ensuring safety and efficacy. The FDA employs scientists, physicians and other staff across various centers to review products, conduct inspections, set standards and provide information to consumers. Key responsibilities include approving new drugs, ensuring food safety, regulating medical devices and regulating veterinary products.
The Therapeutic Goods Administration (TGA) regulates therapeutic goods including medicines, medical devices, and biologicals in Australia. The TGA evaluates medicines for quality, safety and efficacy before approval and licensing of manufacturers. It also monitors medicines post-market, including adverse event reporting and compliance with standards. The regulatory framework is established by the Therapeutic Goods Act 1989 which provides a uniform national system and Australian Register of Therapeutic Goods to list approved products.
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.
Pharmacovigilance aims to detect, assess, monitor, understand, and prevent adverse drug reactions. It has evolved over time in response to drug safety issues. Key events include the Thalidomide disaster in the 1960s which led to clinical trials, and the establishment of reporting systems in the UK, US, and Europe. India launched its national pharmacovigilance program in 2010 to monitor adverse drug reactions, but progress in expanding monitoring centers has been slow. Increased funding and commitment are needed to fully establish nationwide pharmacovigilance in India.
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
The document summarizes several regulatory agencies that regulate pharmaceutical products around the world. It discusses the roles and functions of the CDSCO in India, FDA in the United States, TGA in Australia, Health Canada, and MHRA in the UK. For each agency, it provides information on their goals, activities related to drug approval and regulation, and key application forms.
The document discusses several initiatives by the Therapeutic Goods Administration (TGA) to improve patient care, including levels of evidence for complementary medicines, adverse event reporting, and information resources. It describes the TGA's role in regulating medicines, medical devices, and other products. It also explains the two-tiered regulatory system for medicines, requirements for listed complementary medicines, and efforts to make adverse event reporting easier for consumers and pharmacists.
This document provides an overview of regulatory affairs and its importance in the pharmaceutical industry. It discusses how regulatory affairs developed due to governments' desire to control medicine safety and efficacy. The regulatory affairs professional ensures products comply with all regulations. The document outlines some key drug regulation events that prompted stricter laws, such as the 1901 diphtheria antitoxin contamination and the 1960 thalidomide tragedy. It also summarizes the role of regulatory authorities like the FDA and regulatory affairs departments in obtaining marketing authorization and maintaining compliance.
This document discusses pulmonary drug delivery and summarizes 3 research articles on using nanoparticles for pulmonary drug delivery. It begins with an introduction to pulmonary drug delivery and how lungs work. It then discusses how diseases like asthma and COPD affect the lungs. It reviews some common inhaler drugs and advantages and disadvantages of pulmonary delivery. It summarizes 3 research articles that developed nanoparticles coated with chitosan or polymers to deliver drugs like voriconazole or microRNA to treat lung diseases like fungal infections or COPD. The nanoparticles showed improved drug retention and release profiles in the lungs compared to other delivery methods.
This document discusses dandruff, its causes, treatments, and recent research. It begins with an introduction to dandruff and its main cause, the yeast Malassezia furfur. It then explores microbial and non-microbial causes of dandruff. Treatment strategies are classified including lifestyle changes and ingredients like tea tree oil. Three research articles are summarized that formulated and evaluated anti-dandruff gels, shampoos containing tea tree oil, and a herbal shampoo with pomegranate extract. The studies found concentration-dependent antifungal activity against Malassezia furfur and that the formulated products were effective treatments for dandruff.
Clinical data management involves collecting trial data according to regulatory standards. There are three main types of data management systems - pure paper-based, electronic-based, and hybrid systems. A recent study investigated the challenges of mixed-method telephonic data collection for assessing the mental health of healthcare workers during the COVID-19 pandemic in India. While telephonic interviews presented difficulties, the authors concluded it could serve as an alternative to in-person data collection when used carefully.
This document discusses monoclonal antibodies (mAb) and recent research on mAb targeting human epidermal growth factor receptor 2 (HER2). It summarizes 4 research articles describing novel HER2-targeted mAb conjugates or formulations to treat HER2-positive cancers. The articles propose paclitaxel-trastuzumab nanoparticles, doxorubicin-loaded nanoparticles conjugated with anti-HER2 antibodies, pharmacokinetic analysis of the HER2-targeted mAb pertuzumab in gastric cancer patients, and a phase 1 study of an antibody-liposomal doxorubicin conjugate targeting HER2-positive breast cancer. All studies demonstrated specific targeting of HER2-positive cancer cells with improved efficacy and reduced
Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist.
seminar presentation
This document discusses mass spectrometry, including its principles, instrumentation, and applications. Mass spectrometry works by ionizing molecules and measuring their mass-to-charge ratios, producing a mass spectrum. This technique is used to determine molecular masses and structures of unknown compounds. It has various applications in analytical chemistry and biology due to its ability to distinguish between substances with high sensitivity and specificity.
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1. N AM E : - S WA D H I N R O U T R AY
R E G D . N O . : - 2 1 6 1 6 11 0 0 5
M . P H AR M ( P H A R M A C E U T I C S )
G U I D E D B Y: - D R . R AJ A R A M M O H APAT R A
S U B . C O D E : - M P H 1 0 6 S / A
SEMINAR ON REGULATORY
AFFAIRS
TOPIC:- THERAPEUTIC GOODS
ADMINISTRATION
2. CONTENTS:-
• Introduction
• Role of TGA
• TGA structure
• Committees
• ARTG
• Regulation
• Covid-19 vaccine approval and distribution
• References
3. INTRODUCTION
• The Therapeutics Goods Administration(TGA) is a unit of the Australian
Government Department of Health and Ageing, is responsible for
administering the act.
• This act came into effect on 15th February 1991.
• TGA regulates the quality, supply and advertising of medicines, pathology
devices, medical devices, blood products and most other therapeutics. Any
items that claim to have a therapeutic effect, are involved in the
administration of medication.
• Essentially therapeutics goods must be entered on the Australia Register
of Therapeutics Goods(ARTG) before they can be supplied in Australia.(1)
4. ROLE OF THE TGA
• Pre – market evaluation and approval of registered products intended
for supply in Australia.
• Development, maintenance and monitoring of the systems for
listening of medicines;
• Licensing of manufacturers in accordance with international standards
of GMPs.
• Post market monitoring through sampling, adverse event reporting,
surveillance activities and response to public inquires.
• The assessment of medicines for export.
5. TGA STRUCTURE
• The TGA’s offices are grouped into three core groups- market
authorization group, monitoring and compliance group and
regulatory support group.(2)
1. TGA executive
2. Market authorization group(MAG)
3. Monitoring and compliance group(MCG)
4. Regulatory support group
5. Office of regulatory integrity(ORI)
6. COMMITTEES
The TGA is supported in its work by a number of external expert advisory committees,
including
1. Australian Drug Evaluation Committee (ADEC) – for prescription medicine.
2. Adverse Drug Reactions Advisory Committee
3. Medicine Evaluation Committee (MEC) – for the over- the- counter medicines.
4. Complementary Medicines Evaluation Committee(CMEC) – for complementary
medicines.
5. Therapeutic Devices Evaluation Committee (TDEC) – for medical devices.
6. Therapeutic Goods Committee (TGC)
(3)
7. AUSTRALIAN REGISTER OF
THERAPEUTICS GOODS (ARTG)
• A therapeutic good is boardly defined as a good which is represented in
any way to be taken , for therapeutic use.
• ARTG was established under the Therapeutics Goods Act 1989.
• ARTG is a computer database of therapeutic goods. Therapeutics goods
are divided into two classes: medicines and medical devices.
• AUST R – Higher risk medication, all prescription medicines, over–
the–counter products such as antiseptic , cough relief and colds.
• AUST L – Lower risk self medication products. Eg:- vitamin, mineral,
herbal and homeopathic products.
8. ELEMENT TO REGULATE THERAPEUTIC
GOODS
Licensing and audit of manufactures
Pre-market assessment
Post- market regulatory authority
LICENSING AND AUDIT OF MANUFACTURERS
The act requires each Australian manufacturers of medicinal
products for human use to hold a manufacturing license. License holder
are required to comply with the manufacturing principles of the act.
9. PRE- MARKET ASSESSMENT
Premarket assessment consists of two key components:
• Conformity assessment - an independent check that the processes
undertaken by a manufacturer ensure that a medical device complies
with the regulatory requirements for quality, safety and performance;
followed by
• An application (and decision) to include the medical device in the
ARTG.
Listed medicines are low risk medicines and are included on the ARTG
via a low- cost and streamlined electronic application and validation
process.
10. POST- MARKET REGULATORY
AUTHORITY
• Once a medical device has been included in the ARTG the device must
continue to meet all the regulatory, safety and performance requirements
and standards that were required for the approval.
• The TGA has mandatory requirements and ongoing responsibilities for
all manufacturers and sponsors of medical devices.
• Information received by the TGA once a device is included in the ARTG
informs actions including:
Corrective actions including, but not limited to, changes to device
design, construction and information accompanying the device;
Suspension and/or cancellation of the product;
Recall actions including safety alerts; and
Educational resources including website notifications.
11. The following pages contain information relating to ongoing post-market
responsibilities and activities for sponsors and manufacturers:
• Sponsor's ongoing responsibilities
• Distribution records
• Manufacturer's ongoing responsibilities
• Adverse event reporting - sponsors
• Report an adverse event - health professionals and consumers
• Adverse event reporting form - sponsors
• Post market reviews
• Post market review compliance dashboard
• Annual reports
• Changing the sponsor/transferring therapeutic goods
• Recalls
12. COVID-19 VACCINE APPROVAL AND
DISTRIBUTION
Pfizer– BioNtech vaccine
• On 25 January 2021, the TGA provisionally approved the two-
dose Pfizer- BioNtech vaccine, named COMIRNATY, for use
within Australia. The provisional approval only recommends the
vaccine for patients over the age of 16, pending ongoing submission
of clinical data from the vaccine sponsors(the manufacturers, Pfizer
and BioNtech). Additionally, every batch of vaccines have their
composition and documentation verified by TGA laboratories before
being distributed to medical providers.
13. • The Department of Health planned the administration of COVID-19
vaccinations in five phases, organized by the risk of exposure. Border,
quarantine, and front-line health and aged care workers were vaccinated
first, followed by over 70 year-olds, other health care workers, and essential
emergency service members. Following the provisional approval of
COMIRNATY, Prime Minister Scott Morrison said that it was planned for the
first group to begin vaccinations by February 2021, six weeks earlier than
originally planned.
• The first public COVID-19 Vaccine in Australia actually took place on
21 February 2021 with the Pfizer– BioNTech vaccine at Castle hill in Sydney.
• On 23 July 2021, the TGA approved the Pfizer COVID-19 vaccine for
teenagers between 12 to 15 years old.
• On 5 December 2021, the TGA provisionally approved the Pfizer COVID-19
vaccine access for five to 11-year-olds. (4)
14. Oxford–AstraZeneca vaccine
• On 16 February 2021, the Oxford–AstraZeneca vaccine was approved by the
TGA for use in Australia. The administration of this vaccine is scheduled to
start in March.
• Two weeks later, on 28 February, the first shipment of the vaccine, around
300,000 doses, arrived at Sydney for rollout from 8 March. On 5 March 2021,
Italy stopped the export of AstraZeneca vaccine to Australia due to their
slower rollout of that vaccine in the EU.
• On 23 March, TGA approved the first batch of locally manufactured
AstraZeneca vaccine by CSL-Seqirus in Melbourne, and 832,200 doses were
ready for rollout in the following weeks. (5)
15. REFERENCES
1. "TGA basics". Therapeutic Goods Administration. Retrieved 25
January 2021.
2. "Structure". Therapeutics Goods Administration. 16 October 2020.
Retrieved 25 January 2021
3. "Committees". Therapeutic Goods Administration. Retrieved 25
January 2021.
4. Worthington, Brett "Australia secures additional Pfizer vaccine following
AstraZeneca concerns” Retrieved 9 April 2021.
5. Haydar, Nour "Federal government projects little need for AstraZeneca
COVID-19 vaccine after October” Retrieved 24 June 2021.
WEBSITES:-
1. https://www.tga.gov.au/
2. tga.gov.au/covid-19-vaccine-pfizer-australia-comirnaty-tozinameran-mrna
3. https://odc.gov.au/