The document provides information about various regulatory authorities that regulate medicines and medical devices. It discusses the US FDA, UK MCA, TGA of Australia, and their roles and responsibilities. The US FDA regulates food, drugs, medical devices, cosmetics, and other products in the US. The UK MCA was formed by merging the MCA and MDA and is responsible for ensuring medicines and devices are safe and work properly in the UK. The TGA regulates therapeutic goods including medicines and medical devices to ensure their quality, safety and performance in Australia.
In this presentation I have mentioned whatever the possible relevant content required for the title.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
Regulatory requirement for setting herbal drug industryRAGHAV DOGRA
The World Health Organization (WHO) estimates that 80 percent of the population of some Asian and African countries presently use herbal medicine for some aspect of primary health care.Pharmaceuticals are prohibitively expensive for most of the world's population, half of whom lived on less than $2 U.S. per day in 2002. In comparison, herbal medicines can be grown from seed or gathered from nature for little or no cost
patent (/ˈpætənt/ or /ˈpeɪtənt/) is a set of exclusive rights granted by a sovereign state to an inventor or assignee for a limited period of time in exchange for detailed public disclosure of an invention. An invention is a solution to a specific technological problem and is a product or a process. Patents are a form of intellectual property.
This document provides documentation of the raw material analysis conducted for croscarmellose sodium submitted by Jaya Prakash V. It introduces the importance of documentation in the pharmaceutical industry and discusses good documentation practices. The document then analyzes the raw material croscarmellose sodium against specifications in the British Pharmacopoeia, including tests for identification, microbial limits, pH, loss on drying, heavy metals, and settling volume. The conclusion indicates that croscarmellose sodium passed all acceptance tests for the analyzed parameters.
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.
This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state.
New Drug approval process in India, rules, and regulation according to schedule Y (Drug and cosmetics act 1940 ).
Fees and form for the submission of application.
Pharmaceutical Jurisprudence SCHEDULES
By_ Nakul Dhore
❖Schedules to the Act (02)
❖Schedules to the Rules (23)
❖Appendices (06)
❖Important Acts & Years
❖Multiple Choice Questions
Pharmaceutical Jurisprudence
Semester 5
As Per PCI Syllabus (New)
In this presentation I have mentioned whatever the possible relevant content required for the title.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
Regulatory requirement for setting herbal drug industryRAGHAV DOGRA
The World Health Organization (WHO) estimates that 80 percent of the population of some Asian and African countries presently use herbal medicine for some aspect of primary health care.Pharmaceuticals are prohibitively expensive for most of the world's population, half of whom lived on less than $2 U.S. per day in 2002. In comparison, herbal medicines can be grown from seed or gathered from nature for little or no cost
patent (/ˈpætənt/ or /ˈpeɪtənt/) is a set of exclusive rights granted by a sovereign state to an inventor or assignee for a limited period of time in exchange for detailed public disclosure of an invention. An invention is a solution to a specific technological problem and is a product or a process. Patents are a form of intellectual property.
This document provides documentation of the raw material analysis conducted for croscarmellose sodium submitted by Jaya Prakash V. It introduces the importance of documentation in the pharmaceutical industry and discusses good documentation practices. The document then analyzes the raw material croscarmellose sodium against specifications in the British Pharmacopoeia, including tests for identification, microbial limits, pH, loss on drying, heavy metals, and settling volume. The conclusion indicates that croscarmellose sodium passed all acceptance tests for the analyzed parameters.
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.
This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state.
New Drug approval process in India, rules, and regulation according to schedule Y (Drug and cosmetics act 1940 ).
Fees and form for the submission of application.
Pharmaceutical Jurisprudence SCHEDULES
By_ Nakul Dhore
❖Schedules to the Act (02)
❖Schedules to the Rules (23)
❖Appendices (06)
❖Important Acts & Years
❖Multiple Choice Questions
Pharmaceutical Jurisprudence
Semester 5
As Per PCI Syllabus (New)
A) Study in detail about Para - IV filing. B) Case studies for Para - IV Filing.Aakashdeep Raval
This document discusses paragraph IV (P-IV) filings under the Hatch-Waxman Act. It provides details on:
1) P-IV filings allow generic drug companies to file an Abbreviated New Drug Application (ANDA) to challenge a patent before it expires.
2) If the original drug company sues for patent infringement within 45 days, approval is automatically stayed for 30 months.
3) The first generic company to file a successful P-IV challenge receives 180 days of market exclusivity prior to other generics entering.
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT Sagar Savale
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
Manufacture of all classes of drug require prior license.
This document discusses solid phase extraction (SPE), a popular sample preparation technique. SPE uses a solid stationary phase to isolate and concentrate analytes from liquid samples. It reduces interference levels and minimizes final sample volumes. The degree of analyte enrichment depends on the selectivity and strength of interaction between the analyte and bonded phase. Common retention mechanisms include non-polar, polar, ionic, and hydrogen bonding interactions. SPE provides flexibility, longer column lifetimes, better contaminant removal, recovery, reproducibility and sensitivity compared to liquid-liquid extraction.
The Certificate of Pharmaceutical Product (CoPP) is issued by the competent authority of the exporting country and provides information to the importing country's regulatory authority regarding a pharmaceutical product's registration and manufacturing standards. A CoPP contains details about the product name, manufacturer, and marketing authorization status in the exporting country. It helps smaller drug regulatory authorities assess a product's quality for registration or importation. The three main purposes of a CoPP are for a product under consideration for marketing authorization in an importing country, to renew an existing authorization, or for administrative review.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
This document summarizes the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 in India. The key points are:
1. The Act aims to control advertisement of drugs in certain cases and prohibit advertisements for remedies alleged to possess magic qualities or that claim treatment of certain diseases.
2. It defines terms like "advertisement", "magic remedy", "drug" and prohibits advertisements of drugs for treating diseases like miscarriage or sexual disorders.
3. The Act also prohibits misleading drug advertisements and those referring to magic remedies for treating specified diseases. It establishes penalties for violations.
Impurities in Drug Substance & in Drug ProductKamal Ambalia
The document provides guidance on impurities in drug substances and products. It discusses the classification of impurities into organic, inorganic, and residual solvents. It describes the rationale for reporting and controlling impurities and outlines identification thresholds, reporting thresholds, and qualification thresholds based on maximum daily dose. Analytical procedures for impurity detection and identification must be validated. Impurities above thresholds require identification and qualification. The new drug specification must include impurities above reporting thresholds. Residual solvent limits are based on ICH Q3C guidelines.
Regulatory requirements for herbal medicines: Herbal medicines are different from other types of medicines. The approval process is also different from other medicines. AYUSH Ministry given guidelines for approval of herbal medicines.
Query Solved
1. Regulatory requirements for herbal medicines
2. Herbal Medicines ke liye regulatory requirements
3. AYUSH ka important role in Herbal medicines launch
4. D and C act role in Herbal medicines
5. What are important steps to launch herbal medicines
The Drug and Magic Remedies Act of 1954 aims to control drug advertising and prohibit advertisements for magic remedies. Key points:
- It prohibits advertisements of drugs used for abortion, contraception, or sexual pleasure, as well as misleading drug ads. Magic remedy ads for specified diseases are also banned.
- Exempted advertisements include signs at registered medical practitioners' offices and information in bona fide scientific publications. Ads providing therapeutic, administration, dosage and side effect information to practitioners are also allowed.
- Diseases that cannot be claimed cured include blindness, AIDS, goiter, tuberculosis, high blood pressure, sexual problems, cancer, epilepsy, paralysis and menstrual disorders.
- Penalties for violating the
The document discusses the objectives and guidelines of the International Council for Harmonization (ICH) for stability testing of pharmaceutical products. It provides an overview of the key ICH guidelines for stability testing (Q1A-Q1F) and describes the principles of stability testing including establishing re-test periods and shelf lives. It also discusses the different types of stability testing, protocols, study designs like bracketing and matrixing, and key parameters for evaluation.
The document provides an overview of drug regulatory affairs. It discusses how regulatory affairs developed to protect public health by controlling drug safety and efficacy. Regulatory affairs experts play an important role in managing a product's life cycle and ensuring compliance with laws and regulations. They act as a liaison between companies and regulatory bodies like CDSCO. Key responsibilities include assisting with licensing, registrations, clinical trials and maintaining required documents. The document also outlines some of the major acts governing drug regulation in India like the Drugs and Cosmetics Act.
This document summarizes registration requirements for medicines in three CIS countries - Uzbekistan, Georgia, and Kyrgyzstan. Uzbekistan requires chemical, pharmaceutical, biological, pharmacological, toxicological and clinical documentation be submitted. Georgia requires administrative documents, labeling information approved in the exporting country, and samples. Kyrgyzstan requires an application, power of attorney, GMP certificate, product description and stability data. All three countries require documentation be submitted in their local languages and require stability testing in Zone I conditions.
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.
This document summarizes the determination of residual solvents in pharmaceuticals by gas chromatography according to ICH guidelines. Residual solvents are organic chemicals used in manufacturing that are not fully removed and may pose health risks. They are classified into Class 1, 2, or 3 based on toxicity, with Class 1 solvents prohibited. Gas chromatography with headspace injection and flame ionization detection is the primary analytical method. It involves using capillary columns, temperature programs, and identifies solvents by comparing retention times to standards. The document outlines accepted chromatographic conditions and procedures A, B, and C described in pharmacopeias.
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.
This document discusses FDA's efforts to standardize regulatory data submissions through the use of data standards and the Janus initiative. It provides background on the large and growing volumes of submissions received by FDA. It then describes the challenges of disparate data formats and lack of standards. The vision is outlined for a standardized approach using exchange standards like SDTM and terminology standards. The Janus initiative aims to create a centralized data infrastructure within FDA to improve management and analysis of scientific data submissions and help modernize the review process.
This document discusses the requirements for manufacturing facilities and clinical trials in India according to Schedules M and Y of the Drugs and Cosmetics Rules. Schedule M outlines the good manufacturing practices and requirements for premises, plants, and equipment used in pharmaceutical production. It also discusses facility design aspects like clean surroundings, building facilities, lighting, ventilation, and storage areas. Schedule Y provides the guidelines for conducting clinical trials in India, including the various phases of trials from Phase 0 to Phase IV. It also discusses aspects like informed consent, ethics committee composition, and government facilities for expediting clinical trials.
This document provides a summary of the key steps to implement ICH Q3D Guideline for Elemental Impurities:
1. Collect baseline information on potential elemental impurity sources from suppliers.
2. Define the risk assessment strategy to use, such as the component-based Options 1, 2A, 2B or finished-product Option 3.
3. Develop an analytical plan using techniques like ICP-MS to test for elemental impurities.
4. Establish a control strategy where impurities below 30% of the PDE are acceptable.
5. Manage the implementation as a continuous process, reassessing for product or supplier changes.
This document provides an overview of drug master files (DMFs), including:
- The different types of DMFs and the content they contain
- Requirements for DMF submissions format and delivery methods
- The review process DMFs go through at regulatory agencies
- Requirements for annual reports and closure of DMFs
- Status indicators for DMFs in the FDA database
- Similarities and differences between US DMFs and European DMFs/ASMFs
This document provides an overview of the United States Food and Drug Administration (USFDA). It discusses the history and definition of the USFDA, its objectives to ensure safety of foods, drugs, cosmetics and medical devices. It outlines the various components of the USFDA including the Center for Drug Evaluation and Research (CDER), Center for Food Safety and Applied Nutrition (CFSAN), and Center for Veterinary Medicine (CVM). It also discusses the FDA's evaluation process, mission, laws enforced, and activities regulated.
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.
A) Study in detail about Para - IV filing. B) Case studies for Para - IV Filing.Aakashdeep Raval
This document discusses paragraph IV (P-IV) filings under the Hatch-Waxman Act. It provides details on:
1) P-IV filings allow generic drug companies to file an Abbreviated New Drug Application (ANDA) to challenge a patent before it expires.
2) If the original drug company sues for patent infringement within 45 days, approval is automatically stayed for 30 months.
3) The first generic company to file a successful P-IV challenge receives 180 days of market exclusivity prior to other generics entering.
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT Sagar Savale
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
Manufacture of all classes of drug require prior license.
This document discusses solid phase extraction (SPE), a popular sample preparation technique. SPE uses a solid stationary phase to isolate and concentrate analytes from liquid samples. It reduces interference levels and minimizes final sample volumes. The degree of analyte enrichment depends on the selectivity and strength of interaction between the analyte and bonded phase. Common retention mechanisms include non-polar, polar, ionic, and hydrogen bonding interactions. SPE provides flexibility, longer column lifetimes, better contaminant removal, recovery, reproducibility and sensitivity compared to liquid-liquid extraction.
The Certificate of Pharmaceutical Product (CoPP) is issued by the competent authority of the exporting country and provides information to the importing country's regulatory authority regarding a pharmaceutical product's registration and manufacturing standards. A CoPP contains details about the product name, manufacturer, and marketing authorization status in the exporting country. It helps smaller drug regulatory authorities assess a product's quality for registration or importation. The three main purposes of a CoPP are for a product under consideration for marketing authorization in an importing country, to renew an existing authorization, or for administrative review.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
This document summarizes the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 in India. The key points are:
1. The Act aims to control advertisement of drugs in certain cases and prohibit advertisements for remedies alleged to possess magic qualities or that claim treatment of certain diseases.
2. It defines terms like "advertisement", "magic remedy", "drug" and prohibits advertisements of drugs for treating diseases like miscarriage or sexual disorders.
3. The Act also prohibits misleading drug advertisements and those referring to magic remedies for treating specified diseases. It establishes penalties for violations.
Impurities in Drug Substance & in Drug ProductKamal Ambalia
The document provides guidance on impurities in drug substances and products. It discusses the classification of impurities into organic, inorganic, and residual solvents. It describes the rationale for reporting and controlling impurities and outlines identification thresholds, reporting thresholds, and qualification thresholds based on maximum daily dose. Analytical procedures for impurity detection and identification must be validated. Impurities above thresholds require identification and qualification. The new drug specification must include impurities above reporting thresholds. Residual solvent limits are based on ICH Q3C guidelines.
Regulatory requirements for herbal medicines: Herbal medicines are different from other types of medicines. The approval process is also different from other medicines. AYUSH Ministry given guidelines for approval of herbal medicines.
Query Solved
1. Regulatory requirements for herbal medicines
2. Herbal Medicines ke liye regulatory requirements
3. AYUSH ka important role in Herbal medicines launch
4. D and C act role in Herbal medicines
5. What are important steps to launch herbal medicines
The Drug and Magic Remedies Act of 1954 aims to control drug advertising and prohibit advertisements for magic remedies. Key points:
- It prohibits advertisements of drugs used for abortion, contraception, or sexual pleasure, as well as misleading drug ads. Magic remedy ads for specified diseases are also banned.
- Exempted advertisements include signs at registered medical practitioners' offices and information in bona fide scientific publications. Ads providing therapeutic, administration, dosage and side effect information to practitioners are also allowed.
- Diseases that cannot be claimed cured include blindness, AIDS, goiter, tuberculosis, high blood pressure, sexual problems, cancer, epilepsy, paralysis and menstrual disorders.
- Penalties for violating the
The document discusses the objectives and guidelines of the International Council for Harmonization (ICH) for stability testing of pharmaceutical products. It provides an overview of the key ICH guidelines for stability testing (Q1A-Q1F) and describes the principles of stability testing including establishing re-test periods and shelf lives. It also discusses the different types of stability testing, protocols, study designs like bracketing and matrixing, and key parameters for evaluation.
The document provides an overview of drug regulatory affairs. It discusses how regulatory affairs developed to protect public health by controlling drug safety and efficacy. Regulatory affairs experts play an important role in managing a product's life cycle and ensuring compliance with laws and regulations. They act as a liaison between companies and regulatory bodies like CDSCO. Key responsibilities include assisting with licensing, registrations, clinical trials and maintaining required documents. The document also outlines some of the major acts governing drug regulation in India like the Drugs and Cosmetics Act.
This document summarizes registration requirements for medicines in three CIS countries - Uzbekistan, Georgia, and Kyrgyzstan. Uzbekistan requires chemical, pharmaceutical, biological, pharmacological, toxicological and clinical documentation be submitted. Georgia requires administrative documents, labeling information approved in the exporting country, and samples. Kyrgyzstan requires an application, power of attorney, GMP certificate, product description and stability data. All three countries require documentation be submitted in their local languages and require stability testing in Zone I conditions.
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.
This document summarizes the determination of residual solvents in pharmaceuticals by gas chromatography according to ICH guidelines. Residual solvents are organic chemicals used in manufacturing that are not fully removed and may pose health risks. They are classified into Class 1, 2, or 3 based on toxicity, with Class 1 solvents prohibited. Gas chromatography with headspace injection and flame ionization detection is the primary analytical method. It involves using capillary columns, temperature programs, and identifies solvents by comparing retention times to standards. The document outlines accepted chromatographic conditions and procedures A, B, and C described in pharmacopeias.
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.
This document discusses FDA's efforts to standardize regulatory data submissions through the use of data standards and the Janus initiative. It provides background on the large and growing volumes of submissions received by FDA. It then describes the challenges of disparate data formats and lack of standards. The vision is outlined for a standardized approach using exchange standards like SDTM and terminology standards. The Janus initiative aims to create a centralized data infrastructure within FDA to improve management and analysis of scientific data submissions and help modernize the review process.
This document discusses the requirements for manufacturing facilities and clinical trials in India according to Schedules M and Y of the Drugs and Cosmetics Rules. Schedule M outlines the good manufacturing practices and requirements for premises, plants, and equipment used in pharmaceutical production. It also discusses facility design aspects like clean surroundings, building facilities, lighting, ventilation, and storage areas. Schedule Y provides the guidelines for conducting clinical trials in India, including the various phases of trials from Phase 0 to Phase IV. It also discusses aspects like informed consent, ethics committee composition, and government facilities for expediting clinical trials.
This document provides a summary of the key steps to implement ICH Q3D Guideline for Elemental Impurities:
1. Collect baseline information on potential elemental impurity sources from suppliers.
2. Define the risk assessment strategy to use, such as the component-based Options 1, 2A, 2B or finished-product Option 3.
3. Develop an analytical plan using techniques like ICP-MS to test for elemental impurities.
4. Establish a control strategy where impurities below 30% of the PDE are acceptable.
5. Manage the implementation as a continuous process, reassessing for product or supplier changes.
This document provides an overview of drug master files (DMFs), including:
- The different types of DMFs and the content they contain
- Requirements for DMF submissions format and delivery methods
- The review process DMFs go through at regulatory agencies
- Requirements for annual reports and closure of DMFs
- Status indicators for DMFs in the FDA database
- Similarities and differences between US DMFs and European DMFs/ASMFs
This document provides an overview of the United States Food and Drug Administration (USFDA). It discusses the history and definition of the USFDA, its objectives to ensure safety of foods, drugs, cosmetics and medical devices. It outlines the various components of the USFDA including the Center for Drug Evaluation and Research (CDER), Center for Food Safety and Applied Nutrition (CFSAN), and Center for Veterinary Medicine (CVM). It also discusses the FDA's evaluation process, mission, laws enforced, and activities regulated.
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 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 US Food and Drug Administration (FDA) regulates food, drugs, medical devices, vaccines, and other products in the United States. The FDA is responsible for protecting public health by ensuring the safety and security of these products. It evaluates the safety and efficacy of new drugs and monitors approved drugs for safety issues. The FDA aims to provide accurate science-based information to the public and encourages participation in its regulatory process through public dockets. It works with international authorities like those in India to ensure safety standards for products exported to the US.
The document provides information about the US Food and Drug Administration (FDA):
- The FDA is a regulatory agency within the US Department of Health that is responsible for protecting public health by ensuring the safety of foods, drugs, medical devices, and other products.
- The FDA regulates a wide range of products including biologics, cosmetics, drugs, foods, medical devices, radiation-emitting electronics, veterinary products and tobacco.
- The agency is organized into centers that focus on specific regulatory areas like drugs, biologics, foods and medical devices. Major regulations are codified in the Code of Federal Regulations Title 21.
This document provides an overview of the US Food and Drug Administration (FDA) in 3 paragraphs. It discusses that the FDA was formed in 1906 and is responsible for regulating foods, drugs, medical devices, and other products. It describes the FDA's structure and responsibilities across its centers and offices. The document also provides brief summaries of the FDA approval processes for drugs, medical devices, and food products.
The document provides an overview of the United States Food and Drug Administration (FDA). It discusses the FDA's mission to protect public health by regulating food, drugs, medical devices, and other products. It outlines the FDA's strategic plan, organizational structure, products regulated, laws enforced, and global presence. The FDA works to ensure medical products imported to the US from countries like India, China, and others are safe and effective.
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.
An Investigational New Drug (IND) application allows a sponsor to legally test an unapproved or investigational drug in clinical trials. The sponsor must provide preclinical data on pharmacology, toxicology and manufacturing to show the drug is reasonably safe for initial human testing. After submitting an IND, clinical trials can begin if FDA does not disapprove the application within 30 days. The IND application process and clinical trials are regulated to ensure data quality and subject safety.
The U.S. Food and Drug Administration (FDA) regulates most foods and medical products. It aims to protect public health by ensuring foods are safe and properly labeled, and that medicines, medical devices and cosmetics are reasonably safe and effective. The FDA oversees a large number of companies and conducts facility inspections to ensure compliance with regulations. It can pursue legal action if regulations are violated.
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.
This document provides information about the Food and Drug Administration (FDA). It discusses that the FDA is a federal agency that regulates food, drugs, medical devices, and other products to protect public health. The FDA has approximately 9,000 employees including scientists, inspectors, and medical doctors. It is organized into several program centers responsible for approving products and ensuring safety. The document outlines the FDA's role in regulating key areas like food, drugs, medical devices, vaccines, and more.
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes required by the FDA to develop and approve new drugs. It describes how developing a new drug takes 15 years and over $900 million on average. The IND allows testing of new drugs in humans and provides safety data, while the NDA provides all clinical trial data for the FDA to determine if the drug is safe and effective for approval. Both the IND and NDA are lengthy applications that require extensive non-clinical and clinical data to gain FDA approval to market a new prescription drug.
Ind (investigational new drug application) and ndaswati2084
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes for bringing new drugs to market. It describes how an IND must be submitted to the FDA to test an experimental drug in humans, and outlines the types of INDs, content requirements, and review process. An NDA contains extensive clinical trial data and is required for FDA approval to commercially market a new drug. The lengthy and costly process from initial research to marketing approval averages 15 years and $900 million per new drug.
The document summarizes regulatory affairs for the MHRA and USFDA. It discusses the history and roles of the MHRA in regulating clinical trials, licensing products, and enforcing regulations in the UK. It then outlines the development process for new drugs from discovery through licensing. Finally, it provides an introduction to the USFDA, covering its definition, history, mission, organization, functions, and products regulated.
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
This document provides an overview of biologics, their regulatory approval process in the United States and Europe, and differences between the two regions. It defines biologics as products derived from living organisms used to treat and prevent disease. The US Food and Drug Administration's Center for Biologics Evaluation and Research and the European Medicines Evaluation Agency regulate biologics. Companies must submit a Biological License Application in the US and a Marketing Authorization Application in Europe for product approval, which involves preclinical and clinical testing according to each region's guidelines. The main goal of regulations in both the US and Europe is to safeguard public health.
The document provides an overview of the U.S. Food and Drug Administration (FDA). It discusses the history, mission, organization and functions of the FDA. Key points covered include what products and areas the FDA regulates and does not regulate, FDA advisory committees, the Code of Federal Regulations (CFR), Orange Book, Investigational New Drug applications, New Drug Applications, and other FDA processes.
Automated analysis by yatin sankharva copyPatel Parth
This document discusses automation in pharmaceutical analysis. It covers the benefits of automation including increased speed, accuracy, and reproducibility. It also discusses the classification, basic components, and techniques of automatic analyzers including discrete analyzers and continuous flow analysis. The objectives, approaches, and good practices of automation are summarized as well.
This document discusses automated analysis and its advantages. It describes the need for automation to process large sample volumes efficiently and precisely. The objectives of automation are outlined as facilitating analysis, reducing human error, and lowering costs. Two main types of automated systems are described: discrete analyzers that keep samples separate, and continuous-flow analyzers like flow injection analysis where samples mix in a flowing stream. Key aspects of flow injection analysis include its instrumentation, sample transport and separation techniques. Other automation techniques discussed include discrete automatic systems, automatic sampling, and using robotics.
This document discusses drug Good Manufacturing Practices (GMPs) worldwide and generic drug product registration processes in the US and EU. It provides an overview of GMP guidelines from organizations like WHO, US FDA, EU, and others. It also summarizes the six quality systems for GMP compliance and compares inspection and batch release processes between the US and EU. Finally, it outlines the generic product registration process and common post-approval changes for both the US and EU.
The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs. It provides background on the Hatch-Waxman Act of 1984 which established the ANDA pathway. The key points are:
1. The Hatch-Waxman Act aimed to balance innovation and access to medicines by providing incentives for brand and generic drug companies. It allowed generics to rely on brand safety data and established bioequivalence standards.
2. ANDAs contain data to demonstrate a generic drug is bioequivalent to the brand version. This allows generics to enter the market without duplicative clinical trials, lowering costs.
3. The FDA approves ANDAs if generics meet quality standards and their
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The document discusses various methods for analyzing data, including descriptive, statistical, and multivariate analyses. Statistical analysis makes raw data meaningful by testing hypotheses, obtaining significant results, and drawing inferences. The appropriate analysis depends on the type of measurement, number of variables, and type of statistical inference required. Correlation analysis studies relationships between variables while causal analysis examines how independent variables affect dependents. Multivariate techniques include multiple regression, discriminant analysis, ANOVA, and canonical analysis.
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This document provides information on preformulation studies for new drug development. It discusses:
1. The purpose of preformulation studies is to understand the characteristics of drug components and optimize dosage form manufacturing.
2. Preformulation studies establish the identity, properties, and compatibility of new drug substances to support formulation development and regulatory filings.
3. A variety of analytical techniques are used in preformulation studies including spectroscopy, chromatography, and thermal analysis to characterize drug substances and excipients.
Tablets are one of the most common oral solid dosage forms. They can be produced through compression or molding methods. There are several types of tablets including compressed, sugar-coated, film-coated, enteric-coated, and controlled-release tablets. Tablets contain active drug ingredients along with excipients that serve various purposes like diluents, binders, lubricants, disintegrants, and colors. Excipients are carefully selected to provide tablets with properties like hardness, disintegration, and appropriate dissolution for drug release.
Solid state analysis techniques like vibrational spectroscopy (FTIR, Raman), UV-VIS diffuse reflectance spectroscopy, and solid state NMR spectroscopy can characterize pharmaceutical solids at the molecular, particulate, and bulk levels. These techniques provide information on polymorphisms, solvatomorphisms, interactions, and degradation pathways important for development and quality assurance of solid dosage forms. Careful solid state characterization is necessary for control of manufacturing processes and formulation.
The document provides guidance on good manufacturing practices for the production of active pharmaceutical ingredients. It discusses quality management, personnel, facilities, equipment, documentation, materials management, production controls, and other quality assurance aspects of API manufacturing. The objective is to help ensure APIs meet quality and purity standards.
The document discusses various techniques for amino acid analysis. It defines amino acids and explains that 20 are encoded by the genetic code. There are essential and non-essential amino acids. Amino acid analysis involves hydrolyzing proteins into individual amino acids, separating them using chromatography, and quantifying amounts. Common techniques discussed include determining amino acid composition, Edman degradation, and mass spectrometry.
The chi-square test is used to determine if an observed frequency distribution differs from an expected theoretical distribution. It can test goodness of fit, independence of attributes, and homogeneity. The test involves calculating chi-square by taking the sum of the squares of the differences between observed and expected frequencies divided by expected frequencies. For the test to be valid, certain conditions must be met regarding sample size, expected frequencies, independence, and randomness. The test has some limitations such as not measuring strength of association and being unreliable with small expected frequencies.
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Radioimmunoassay is an assay technique that uses the binding of antigens and antibodies to measure concentrations of substances. It uses a radioactive tracer that competes with the antigen in a sample for binding to a limited number of antibodies. This allows quantification by measuring the bound versus unbound radioactive tracer. RIA has high sensitivity and specificity, and has revolutionized research and clinical practice in areas like endocrinology, pharmacology, and cancer detection.
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The document discusses pyrogen testing techniques including the rabbit test and LAL (Limulus Amebocyte Lysate) test. It provides details on how to conduct the rabbit test, including temperature monitoring and criteria for a passing result. For the LAL test, it describes the mechanism, different methods (gel clot, turbidimetric, chromogenic), and procedures for confirming lysate sensitivity and determining endotoxin levels in samples. It notes that various pharmacopeias like IP, BP, and USP specify methods for the LAL test.
1. Presented by :
PARTH
M.Pharm (sem:2)
Department of Quality Assurance
K.B.Raval College of Pharmacy
Enroll. no. :11
Guided By:
Pranit Patel
Jan 25, 2013 1
2. STANDARD INSTITUTE:
BSS: British Standard Specification
ISO: International Organization for Standardization
ASTM: American Society for Testing and Materials
ISI: Indian Standard Institution
REGULATORY AUTHORITY:
US FDA: United States Food and Drug Administration
MHRA: The Medical Health and Regulatory Agency ( MCA + MDA)
MDA: The Medical Devices Agency
UK MCA: The Medicine Control agency
TGA: Therapeutic Goods Administration
WHO: World Health Organization
Jan 25, 2013 2
4. USFDA is a government agency of the United States,
Department of Health and Human Services.
The FDA is responsible for regulating and supervising the
safety of
o Foods
o Tobacco products
o Dietary supplements
o Prescription and non-prescription medications
o Vaccines
o Biopharmaceuticals
o Blood transfusions
o medical devices
o Electro magnetic radiation emitting devices
o veterinary products
o cosmetics
Jan 25, 2013 4
5. Scope
• To provide safe and effective Medicine, Biological and
Medicinal devices.
• To provide safe, effective and sanitary Food.
• To provide truthful and informative label.
• To provide safe and effective Animal Drugs.
• For facilitating safe consumer and Medical Radiation
products.
Jan 25, 2013 5
6. Definition by the Food and Drug Administration
“Medical Device”
• A device is:
• "an instrument, apparatus, implement, machine, implant, in
vitro reagent, or other similar or related article, including a
component part, or accessory which is:
-recognized in the official National Formulary, or the United
States Pharmacopoeia, or any supplement to them,
-intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention
of disease, in man or other animals
Jan 25, 2013 6
7. Objectives:
Better consumer information
Post marketing safety
New product review
Keep watch on safe manufacturing and handling
Monitoring for new risk
Standardization and regulation
Enforcement and corrective problem
Jan 25, 2013 7
8. Regulatory Programs
The programs for safety regulation vary widely by the
type of product, its potential risks, and the regulatory
powers granted to the agency.
For example, the FDA regulates almost every part of
prescription drugs, including testing, manufacturing,
labeling, advertising, marketing, efficacy and safety,
FDA regulation of cosmetics is focused primarily on
labeling and safety.
Jan 25, 2013 8
9. Regulatory Programs
(continue)
1. Food and dietary supplements
• The Center for Food Safety and Applied Nutrition is
the branch of the FDA which is responsible for
ensuring the safety and accurate labeling of nearly
all food products in the United States.
2. Drugs
• The Center for Drug Evaluation and Research has
different requirements for the three main types of
drug products:
• a) new drugs, b) generic drugs and c) over-the-
counter drugs.
Jan 25, 2013 9
10. a) New drugs
• New drugs receive extensive scrutiny before FDA
approval in a process called a New Drug Application.
• New drugs are available only by prescription by
default. A change to Over the Counter (OTC) status is
a separate process and the drug must be approved
through an NDA first.
Jan 25, 2013 10
11. a) New drugs (cont.)
Advertising and promotion
• The drug advertising regulation contains two key
requirements. Under most circumstances, a company may
only advertise a drug for the specific indication or
medical use for which it was approved.
• Also, an advertisement must contain "fair balance"
between the benefits and risks of a drug.
Jan 25, 2013 11
12. a) New drugs (cont.)
Post market safety surveillance
• After approval of an NDA, the sponsor must review
and report to the FDA every patient adverse drug
experience of which it learns.
• Unexpected serious and fatal adverse drug events
must be reported within 15 days; other events on a
quarterly basis.
Jan 25, 2013 12
13. b) Generic drugs
• Generic drugs are chemical equivalents of name-
brand drugs whose patents have expired.
• Generally they are less expensive than their name
brand counterparts, are manufactured and marketed
by other companies and, in the 1990s, accounted for
about a third of all prescriptions written in the United
States.
Jan 25, 2013 13
14. c) Over-the-counter drugs
• Over-the-counter (OTC) drugs are drugs and
combinations that do not require a doctor's
prescription.
• The FDA has a list of approximately 800 approved
ingredients that are combined in various ways to
create more than 1,00,000 OTC drug products.
Jan 25, 2013 14
15. 3) Vaccines, blood and tissue products, and
biotechnology
• The Center for Biologics Evaluation and Research is
the branch of the FDA responsible for ensuring the
safety and efficacy of biological therapeutic agents.
• These include blood and blood products, vaccines,
allergenic, cell and tissue-based products, and gene
therapy products.
Jan 25, 2013 15
16. 4) Medical and radiation-emitting devices
• The Center for Devices and Radiological Health
(CDRH) is the branch of the FDA responsible for the
premarket approval of all medical devices, as well as
overseeing the manufacturing, performance and
safety of these devices.
• CDRH regulatory powers include the authority to
require certain technical reports from the
manufacturers or importers of regulated products, to
require that radiation-emitting products meet
mandatory safety performance standards.
Jan 25, 2013 16
17. 4) Cosmetics
• Cosmetics are regulated by the Center for Food
Safety and Applied Nutrition, the same branch of the
FDA that regulates food.
• Cosmetic products are not generally subject to pre-
market approval by the FDA unless they make
"structure or function claims" which make them into
drugs
Jan 25, 2013 17
18. 5) Veterinary products
• The Center for Veterinary Medicine (CVM) is the branch
of the FDA which regulates food, food additives, and
drugs that are given to animals, including food animals
and pets.
• CVM does not regulate vaccines for animals; these are
handled by the United States Department of Agriculture
Jan 25, 2013 18
19. Year Advancement in FDA
1820 U.S Pharmacopoeia
1897 Drug importation Act
1883 Bureau of Chemistry’s Food adulteration Studies
1902 The Biologics Control Act
1906 The original Food and Drugs Act is passed
1933 Complete revision of the obsolete 1906 Food and Drugs Act.
1907 Certified Color Regulations
1937 Elixir of Sulfanilamide, containing the poisonous solvent diethylene
glycol, kills 107 persons,
1939 First Food Standards
1949 Guidence to industry On procedure for the appraisal of toxicity of
chemical in food.
1954 Radiological examination of food
1966 Child protection act
1971 National centre for Toxicological research
1976 Medical device amendments
1982 Temper resistant packaging regulations
1994 Dietary supplement health and education act
Jan 25, 2013 19
2004 Food allergy labeling and consumer protection act
20. FDA Components:
Sr. Componen Full Form Regulates
no t
A CBER Center For Biologics Biological Products.
Evaluation And
Research
B CDRH Center For Devices Safety and Effectiveness of
And Radiologic Health New medical Devices Before
they are Marketed.
C CDER Center For Drug Assuring Prescription and OTC
Evaluation And Drugs are Safe and Effective.
Research
D CSFAN Center For Food Food Supply is Safe, Sanitary,
Safety And Applied Wholesome and Honestly
Nutrition labeled.
E CVM Center For Vaterinary Assure that Animal Food
Medicines Products are Safe
F NCTR National Center For Human Toxicology
Jan 25, 2013 Toxicological Research 20
21. FDA REGULATES
• FDA is the federal agency responsible for ensuring that
foods are safe, wholesome and sanitary; human and
veterinary drugs, biological products, and medical
devices are safe and effective; cosmetics are safe; and
electronic products that emit radiation are safe.
• FDA also ensures that these products are honestly,
accurately and informatively represented to the public.
Jan 25, 2013 21
22. Biologics
product and manufacturing establishment licensing
safety of the nation's blood supply
research to establish product standards and develop
improved testing methods
Cosmetics
safety
labeling
Drugs
product approvals
OTC and prescription drug labeling
drug manufacturing standards
Jan 25, 2013 22
23. Foods
labeling
safety of all food products (except meat and poultry)
bottled water
Medical Devices
premarket approval of new devices
manufacturing and performance standards
tracking reports of device malfunctioning and serious
adverse reactions
Jan 25, 2013 23
24. Radiation-Emitting Electronic Products
radiation safety performance standards for microwave
ovens, television receivers, diagnostic x-ray
equipment, cabinet x-ray systems laser products,
ultrasonic therapy equipment, mercury vapor lamps.
Veterinary Products
livestock feeds
pet foods
veterinary drugs and devices
Jan 25, 2013 24
25. What FDA Does?
Responsible for advancing the public health
To speed innovations that make medicines and foods
more effective, safer, and more affordable
Helping the public get the accurate, science-based
information they need to use medicines and foods to
improve their health.
Jan 25, 2013 25
27. UK MCA
Introduction
The Medical Health and Regulatory Agency (MHRA) was
set up in April 2003 from a merger of the Medicines Control
Agency (MCA) and the Medical Devices Agency(MDA).
The MHRA is the government agency which is responsible
for ensuring that medicines and medical devices work, and
are acceptably safe.
The MHRA is an executive agency of the Department of
Health.
Jan 25, 2013 27
28. Mission
To enhance and protect the health of the public by
ensuring that medicines and medical devices work, and
are acceptably safe.
Values
To fulfill this mission they will act with:
Integrity
Openness
Responsiveness
Timeliness
Professionalism
Impartiality
Consistency
Jan 25, 2013 28
29. AIMS OF UK MCA
Protecting public health through regulation, with
acceptable benefit-risk profiles for medicines and devices.
Promoting public health by helping people who use these
products to understand their risks and benefits.
Improving public health by encouraging and facilitating
developments in products that will benefit people.
Jan 25, 2013 29
30. OBJECTIVE OF UK MCA
Protect public health through ensuring that the
products meet required standards that are safe.
To communicate healthcare professionals, patients
and the public through the provision of accurate,
timely and authoritative information.
Influence the regulatory framework through use of
European and International organizations.
Run an organization with a skilled and equipped
workforce that improve standard.
Jan 25, 2013 30
31. UK MCA's Structure
The MHRA's main activities are supported by various
divisions which are responsible for information
management, providing executive support services,
human resources and finance.
1)The Agency Board: Made up of a non-executive
Chairman, six non-executive members and the
Agency's Chief Executive Officer.
2)The Chief Executive: Responsible for service delivery
and resources.
3)The Executive Board: Consisting of the Agency's
directors, takes overall responsibility for day-to-day
management,
4)The Risk and Audit Committee:
Jan 25, 2013 31
32. UK MCA's Activities:
Assessing the safety, quality and efficacy of
medicines, and authorizing their sale or supply in the
UK for human use.
Operating a positive compliance programmed for
medical devices.
Regulating clinical trials of medicines and medical
devices.
Jan 25, 2013 32
33. UK MCA's Activities(continue):
Monitoring and ensuring compliance with legal
obligations relating to medicines and medical devices
through inspection, taking enforcement action where
necessary
Promoting good practice in the safe use of medicines and
medical devices;
Managing the General Practice Research Database
(GPRD) and the British Pharmacopoeia (BP) and
contributing to the development of standards for medical
devices
Jan 25, 2013 33
34. UK MCA's Activities(continue):
Offering scientific, technical and regulatory advice on
medicines and medical devices;
Providing the public with authoritative information to
enable informed dialogue on treatment choices.
Jan 25, 2013 34
35. What UK MCA regulate?
It regulates a wide range of materials;
Medicines
Medical devices
Blood
Therapeutic products/services that are derived from
tissue engineering.
Jan 25, 2013 35
36. OTHER REGULATORY AGENCIES
CONTROLLED BY UK MCA
1) National Patient Safety Agency (NPSA)
2) National Reporting and Learning Agency (NPLA)
3) National Clinical Assessment Service (NCAS)
4) National Research Ethics Service (NRES)
5) Care Quality Commission (CQC)
6) National Institute for Health and Clinical
Excellence (NICE)
Jan 25, 2013 36
38. TGA (Therapeutic Goods
Administration)
The Therapeutic Goods Administration (TGA) is a
unit of the Australian Government Department of
Health and Ageing and is responsible for
administering the provisions of the legislation.
The TGA carries out a range of assessment and
monitoring activities to ensure therapeutic goods
available in Australia are of an acceptable standard.
Jan 25, 2013 38
39. Purpose:
This guideline provides a general introduction to the
regulatory process for medicines in Australia. It is
designed to help you determine whether your product
is likely to be regulated by the TGA.
Jan 25, 2013 39
40. What is a therapeutic good?
Therapeutic good is broadly defined as a good which
is represented in any way to be, or is likely to be
taken to be, for therapeutic use (unless specifically
excluded or included under Section 7 of the
Therapeutic Goods Act 1989).
Any product for which therapeutic claims are made
must be either listed or registered in the Australian
Register of Therapeutic Goods.
Jan 25, 2013 40
41. Objective of the Therapeutic
Goods Act 1989:
To provide a national framework for the
regulation of therapeutic goods in Australia
To ensure the quality, safety and efficacy of
medicines
To ensure the quality, safety and performance of
medical devices.
Jan 25, 2013 41
42. 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 listing of medicines;
Licensing of manufacturers in accordance with
international standards of Good Manufacturing
Practice;
Post-market monitoring through sampling, adverse
event reporting, surveillance activities, and response to
public inquiries;
Assessment of medicines for export.
Jan 25, 2013 42
43. Australian Register of
Therapeutic Goods (ARTG)
The ARTG is established under Part 3 of the Act.
Includes a computer database of information about
therapeutic goods for human use which are approved
for supply in, or export from, Australia.
Jan 25, 2013 43
44. Assessment criteria:
Whether a product is listed or registered in the ARTG
depends largely on three things:
Ingredients;
Dosage form of the product; and,
Promotional or Therapeutic claims made for the
product.
Jan 25, 2013 44