REGULATORY REQUIREMENTS OF TGA AND ROW COUNTRIES.pptx

This presentation contains the details about regulatory requirements of TGA and ROW countries. It includes the mission of Theraputic Good Admintration(TGA), TGA Regulation, Post market vigilance, Regulatory requirements for (Rest Of the World) ROW countries, importance of hermonization, Pharmacutical markets (Regulated market and semi regulated market) etc.

1. PRESENTED BY- NURUL ISLAM JUBIN NATH M.PHARM, 1ST SEMESTER GIPS-GUWAHATI

2. CONTENTS INTRODUCTION THERAPEUTIC GOODS ADMINISTRATION(TGA) ROW COUNTRIES CONCLUSION REFERENCES

3. INTRODUCTION A regulatory requirement is a rule that a government imposes on an organization. Some federal and state laws govern virtually all organizations. Regulations govern how organizations manage their business and employees and how they interact with customers, among many other areas. Regulatory requirements are massively important in today's technological world. With an ever-growing pool of threats, their primary purpose is to protect. In some industries, this means physically protecting the well-being of people. In others, regulators aim to protect assets, data and integrity.

4. THERAPEUTIC GOODS ADMINISTRATION(TGA) Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia . TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods that are available in Australia are of an acceptable standard. The objectives of Therapeutic Goods Act, 1989 which came into effect on 15 Feb,1991 is to provide a national framework for the regulation of therapeutic goods in Australia to ensure quality, safety & efficacy of the medicines and ensure quality, safety & performance of medical devices .

5. Essentially therapeutic goods must be entered on the Australian Register of Therapeutics Goods(ARTG) before they can be supplied in Australia. ARTG is a computer database of information about therapeutic goods for human use approved for supply in, or export from Australia . Australian manufacturers of all medicines must be licensed under part 4 of the Therapeutic Goods Act, 1989 and their manufacturing process must be comply with the principles of GMP.

6. MISSION OF TGA To ensure that medicines and medical devices in the market are safe and of high quality. To provide a national framework for the regulation of therapeutic goods in Australia and ensure their quality, safety & efficacy. To ensure public health and safety and freeing industry from any unnecessary regulatory burden.

7. TGA REGULATION TGA controls supply of therapeutic goods through three main processes Pre-market assessment Licensing of manufacturers Post-market vigilance

8. PRE-MARKET ASSESSMENT Products assessed as having a higher level of risk (prescription medicines, some non prescription medicines and medical devices) are evaluate for quality, safety and efficacy. Once approved for marketing in Australia these products are included in the ARTG as ‘registered’ products and are identified by an AUST R Number . Products assessed as being lower risk (many non prescription medicines) are assessed for quality and safety.

9. Once approved for marketing in Australia these products are included in the ARTG as ‘listed’ products and are identified by an AUST L Number . In assessing the level of risk, factors are to be considered such as- Strength of product Side effects Toxicity Potential harm through prolong use Seriousness of the medical condition for which the product is intended

10. LICENSING OF MANUFACTURERS Australian manufacturers of therapeutic goods must be licensed. The manufacturing process must comply with the principle of Good Manufacturing Practice(GMP) The aim of licensing and maintain standards are to protect public health by ensuring that medicines and medical devices meet the required standards of quality assurance and are manufactured in condition that are clean and free of contaminants.

11. POST-MARKET VIGILANCE The essential elements of this systematic risk based approach include- Monitoring of adverse reaction Targeted and random surveillance in the market An effective, responsive and timely recall of product Audit of GMP Effective controls for the advertising of therapeutic goods.

12. R EGULATORY R EQUIREMENTS FOR ROW C OUNTRIES ROW refers to the Rest Of The World countries, also known as the emerging market or semi regulated market.
These regions consist mainly the countries from Asia Pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacific and Gulf have harmonized their regulatory environment up to some extent through The Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) organizations. ROW countries need to harmonize regulations in their respective regions . Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is a diversity of requirements in emerging markets.

13. IMPORTANCE OF HARMONIZATION Reduction in the cost involved in availability of drugs. For maintaining quality requirement of premise. Because of the regional registration requirements.

14. PHARMACEUTICAL MARKET IS DIVIDED INTO FOLLOWING GROUPS 1. Regulated Market: US,UK, EU , Japan, Canada, Australia, New Zealand, and South Africa. 2. Semi regulated Market: (a) Asia: (Sri-Lanka, India, Bangladesh, China, Pakistan, Bhutan, Nepal) (b) ASEAN: 10 Countries group - Philippines, Vietnam, Singapore, Malaysia, Thailand, Indonesia, Laos, Cambodia, Brunei Darussalam, and Myanmar. (c) African countries (d) Middle East countries (e) Latin America (Mexico, Brazil, Panama, Peru, Guatemala, Argentina, Chile, Dominican Republic) (f) CIS: (common wealth of independent states): Russia, Ukraine, Post Soviet States (Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kirghizstan, Moldova, Tajikistan, Turkmenistan, and Uzbekistan etc.)

15. COMMON REQUIREMENTS The regulatory requirements for therapeutic goods vary from country to country. However, there are some common requirements, such as: Manufacturing: Most countries have GMP standards that must be met by manufacturers of therapeutic goods. Clinical trials: Clinical trials of therapeutic goods must be approved by the relevant regulatory authority before they can commence. Marketing: Therapeutic goods must be registered with the relevant regulatory authority before they can be marketed in a country. Post-market surveillance: Manufacturers of therapeutic goods must monitor the safety and efficacy of their products after they have been marketed.

16. CONCLUSION The TGA's regulatory requirements are designed to ensure that therapeutic goods are safe, effective, and of high quality. The TGA's requirements are generally aligned with international standards , such as the Good Manufacturing Practice (GMP) guidelines of the International Council for Harmonisation (ICH). However, there are some key differences between the TGA's regulatory requirements and the regulatory requirements of ROW countries. For example, the TGA has a more streamlined pre-market approval process for new therapeutic goods than many ROW countries. Additionally, the TGA has a number of unique regulatory schemes in place, such as the Medical Device Single Audit Program (MDSAP) and the Therapeutic Goods Advertising Code.

17. REFERENCES Preeti Patela , Jitendra Kumar Badjatyab ,*, Madhuri Hingea [Comparative study of regulatory requirements of drug product in emerging market]  Badjatya Jitendra Kumar*, Bodla Ramesh (Department of Pharmacy, J.J.T University, Chudela , Jhunjhunu , Raj. India) (Department of Pharmaceutical Chemistry, DIPSAR New Delhi, India) [Drug Product Registration in semi-regulated market] https://www.tga.gov.au/ https://www.pharma-iq.com/glossary/drug-regulatory

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