The document discusses regulatory requirements for therapeutic goods in Australia and other countries. It begins by introducing regulatory requirements and their importance. It then describes the Therapeutic Goods Administration (TGA) in Australia, which regulates therapeutic goods to ensure quality, safety and efficacy. The TGA approval process involves pre-market assessment, licensing of manufacturers, and post-market vigilance. Regulatory requirements vary across countries but generally involve GMP standards, clinical trial approval, product registration, and post-market surveillance. The document also discusses differences between requirements in regulated countries like Australia and those in the rest of the world.

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. REGULATORY REQUIREMENTS FOR ROW COUNTRIES
● 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

18. THANK YOU