The document provides an overview of various regulatory authorities, including the Therapeutic Goods Administration (TGA) in Australia, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, and the Medicines Control Council (MCC) in South Africa, detailing their roles in ensuring the safety and efficacy of therapeutic goods. It discusses the regulatory programs, guidelines, and organizational structures involved in the assessment and monitoring of medicines and medical devices, emphasizing the importance of compliance with good manufacturing practices. The conclusion highlights the need for a robust regulatory framework to maintain consumer confidence in the quality and safety of complementary medicines.

1. REGULATORY AUTHORITIES
TGA, MHRA, MCC, MCA
Mr. Sagar Kishor savale
[Department of Pharmaceutics]
avengersagar16@gmail.com
Department of Pharmacy (Pharmaceutics) | Sagar savale

2. Contents
1. Introduction
2. History
3. Regulatory Program
4. Organization/Governance
5. Guidelines
6. Conclusion
7. References

3. Therapeutics Goods Administration
Introduction:-1,I
• 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.

4. What are Therapeutic Goods? 1,I
• A ‘therapeutic goods’ 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 good
act 1989.
• Therapeutic goods is a product and connection with:
Preventing , diagnosing , curing or alleviating a disease , defect or injury.
Effecting inhibition or modifying a physiological process .
Testing the susceptibility of person to a disease .
controlling or preventing conception.
Testing for pregnancy.

5. Regulatory program1,I
• The objective of the Therapeutic Goods Act 1989, which came into effect on
15 February 1991, is to provide a national framework for the regulation of
therapeutic goods in Australia to ensure the quality, safety and efficacy of
medicines and ensure the quality, safety and performance of medical devices.
• Essentially therapeutic goods must be entered on the Australian Register Of
Therapeutic Goods (ARTG) before they can be supplied in Australia.
• The ARTG is a computer database of information about therapeutic goods for
human use approved for supply in, or exported from, Australia.

6. Continue..
• Australian manufacturers of all medicines must be
licensed under Part 4 of the Therapeutic Goods Act
1989 and their manufacturing processes must comply with
the principles of GMP (Good Manufacturing Practice).
• Once approved for marketing in Australia, medicines are
included in the ARTG and can be identified by the AUST
R number (for registered medicines) or an AUST L
number (listed medicines) that appears on the packaging
of the medicine.

7. Regulatory Framework for medicineI,6
• The TGA maintains the Australian Register Of Therapeutic
Goods (ARTG), a database that includes details of all
therapeutic goods that are imported into, supplied in, or
exported from Australia.
• In consultation with industry, the TGA has developed the
Australian Regulatory Guidelines For The Complementary
Medicine (ARGCM) to assist sponsors of complementary
medicines to meet their legislative obligations.

8. Purpose of ARGCMII
• Provide information to help sponsors of complementary
medicines to meet their obligations under therapeutic goods
legislation.
• Help ensure that applications to the TGA relating to
complementary medicines uniformly meet all essential
regulatory requirements so that applications may be processed
successfully within minimum timeframes.
• Enhance clarity and transparency of processes leading to the
Registration and Listing of complementary medicines in the
Australian Register of Therapeutic Goods (ARTG).

9. ARGCM Structure and ContentII
• Part I- Provides guidance on the Registration of complementary
medicines.
• Part II- Provides guidance on Listed complementary medicines.
• Part III- Provides guidance on the evaluation of complementary
medicine substances for use in Listed medicines.
• PartIV- Provides general guidance in relation to complementary
medicine modalities such as homoeopathy, traditional herbal
medicine and aromatherapy.
• Part V- Provides details of TGA policy guidelines relevant to
complementary medicines.

10. Regulatory guidelines for OTC medicineIII
• These products are evaluated by the TGA for quality, safety and
efficacy under the provisions of Section 25 of the Therapeutic Goods
Act 1989.
• Products in this category include:
Products that are to be included in the Schedule of Pharmaceutical
Benefits.
 Products that contain a sunscreen active ingredient that is not
included in the list of Sunscreening agents permitted as active
ingredients in listed products;
Products that make therapeutic claims other than sunscreening.
 Products that are not otherwise exempt or listable.

11. Element To Regulate Therapeutic Goods1,I
• Licensing and Audit of Manufactures
• Pre-Market Assessment
• Post-Market Regulatory Authority
• Licensing and Audit of Manufacturers
The Act requires each Australian manufacturer of medicinal products
for human use to hold a manufacturing license. License holders are
required to comply with the manufacturing principles of the Act,
including compliance with Good Manufacturing Practice (GMP).

12. Pre-market Assessment1,I
• These include:
-The toxicity of the ingredients (itself a complex of factors);
-The dosage form of the medicine.
• Medicines that are assessed to be of higher risk are individually
evaluated for quality, safety and efficacy. Higher risk products approved
by the TGA are included on the ARTG as Registered medicines.
• Listed medicines are low risk medicines and are included on the ARTG
via a low-cost and streamlined electronic application and validation
process.

13. How is Risk Assessed?I
• A product risk is determine by a number of factors:-
Side effect
Life threatening or very serious illness
Inappropriate self medication
Adverse effect for prolonged use.

14. Post-market Regulatory Activity1,I
• The essential elements of this systematic risk-based approach include:-
 Targeted and random desk-based audits of Listed products.
 Monitoring of adverse reactions to complementary medicines.
 Targeted and random laboratory testing of products and ingredients.
 Targeted and random surveillance in the market place.
 An effective, responsive and timely recalls procedure.
 Audit of GMP.
 Effective controls for the advertising of therapeutic goods.

15. Fees and ChargesI
From 1 July 1998, the TGA has been required by the
government to fully recover its operating costs for all
activities that falls within the scope of the act, including
regulation of industry and TGA’s public health responsibility.
A list of fees is included in Schedule 9 of the Therapeutic
Goods Regulation 1990.

16. TGA OrganizationI
• Bussiness Management Group
• Executive Support Unit
• Office Of Complementary Medicine
• Office Of Devices,Blood and Tissues
• Office Of Laboratory and Scientific Services
• Office of Manufacturing Quality
• Office of Medicine Safety Monitoring
• Office Of Non-Prescription Medicine

17. The Medicines and Healthcare products
Regulatory Agency1,IV
• The Medicines and Healthcare products Regulatory Agency (MHRA)
is the government agency which is responsible for ensuring that
medicines and medical devices work, and are acceptably safe.
• The MHRA now also looks after blood and blood products, working
with UK blood services, healthcare providers, and other relevant
organizations to improve blood quality and safety.
• The MHRA regulates a wide range of materials from medicines and
medical devices to blood and therapeutic products/services that are
derived from tissue engineering.

18. HistoryIV
• The agency was formed on 1 April2003 with the merger of the
Medicines Control Agency (MCA) and the Medical Devices Agency
(MDA). It is an Executive Agency of the Deparment of Health.
Roles of the MHRA:-
• Operate post-marketing surveillance for reporting investigating and
monitoring of adverse drug reactions to medicines and incidents
with medical devices.
• Assessment and authorization of medicinal products for sale and
supply in uk.

19. • Investigate internet sales and potential counterfeiting of medicines,
and prosecute where necessary.
• Regulate clinical trials of medicines and medical devices.
• Monitor and ensure compliance with statutory obligations relating to
medicines and medical devices.
• Promote safe use of medicines and devices.
• Manage the General Practice Research database and the British
Pharmacopiea.

20. Regulatory Program1,IV
•Assess application for authorization to market products for human use and either
grant authorizations to market each product or reject such applications.
•Assess applications to undertaken clinical trials and grant, or refuse, permission.
•Inspect the manufacturers and wholesalers of medicines for human use and either
grant manufacturing and wholesale licenses or refuse such licenses.
•Undertaken post marketing surveillance including
 Pharmacovigilance
 Quality defect monitoring
 Sampling and testing
 Product recalls

21. Monitoring of Safety and Quality StandardsIV
• The MHRA monitors safety and quality standards by:-
Regular inspections of good and safe practice, including
Medicines manufacture and supply
Medicines distribution and storage
Clinical trials
Auditing of clinical inspecting system for devices
Laboratories testing medicines
Auditing Notified Bodies

22. Dealing with faulty MedicinesIV
• The MHRA’s Defective Medicines Report Centre (DMRC) issues
alerts to healthcare professionals, hospitals, GP surgeries, and
wholesalers to tell them when a medicine is being recalled or
when there are concerns about the quality that will affect its safety
or effectiveness.
Class 1 requires immediate recall, because the product poses a
serious or life threatening risk to health .
 Class 2 specifies a recall within 48 hours, because the defect
could harm the patient but is not life threatening.

23. Continue:
• Class 3 requires action to be taken within 5 days because the
defect is unlikely to harm patients and is being carried out for
reasons other than patient safety.
• Class 4 alerts advise caution to be exercised when using the
product, but indicate that the product poses no threat to patient
safety.

24. MHRA GovernanceIV
• The Agency Board is made up of a non-executive Chairman, six
non-executive members and the Agency's Chief Executive
Officer.
• The Agency's Chief Executive is responsible for service
delivery and resources.
• The Executive Board, consisting of the Agency's directors.

25. MembershipIV
• The Agency Board is chaired by the MHRA Chairman, and consists of
six non-executive directors and the Chief Executive Officer.
• The executive Board’s primary responsibility are to ensure:-
The strategic direction set by the Agency Board is implemented and
reflected in the day to day operations of the Agency.
Principles of good governance are followed.
The Agency is well managed financially.
Appropriate human resources(HR) policies are followed.
Reporting to the Agency Board on the operations of the Agency.

26. Medicines Control Council
• Introduction:-3,V
• South Africa has developed a medicines regulatory authority
with internationally recognized standing.
• The Medicines Control Council (MCC) is a statutory body that
was established in terms of the Medicines and Related
Substances Control Act, 101 of 1965, to oversee the regulation
of medicines in South Africa.

27. HistoryV
• more than 20 000 medicines have been approved.
• more than 220 meetings have been held to decide on the
registration of medicines.
• The South African Pharmacy Council has licensed 300
wholesalers and distributors.
• The Medicines Control Council approves more than 280 clinical
trials annually

28. Regulatory Program3,V
• The Medicines Control Council applies standards laid down by
the Medicines and Related Substances Control Act, (Act 101 of
1965) which governs the manufacture, distribution, sale, and
marketing of medicines.
• The prescribing and dispensing of medicines is controlled.
• The Council has eleven technical committees, with 146
members from various institutions in the country.

29. Continue:
• The MCC operates through external experts who are members of Council
Committee structures. Most experts evaluate data sets submitted by the
pharmaceutical industry for purposes of registration.
• The office of the Registrar provides administrative and technical
support to Council and its activities.The Registrar is also an executive
secretary to Council.

30. Continue:
•The staff complement of Medicines Regulatory Affairs includes doctors,
pharmacists, veterinarians, other scientists and administrative staff.
•The skills of Council and its committees are written into law and include expertise in
toxicology and medicine safety, clinical pharmacology, biotechnology,
pharmaceutics, internal medicine, virology, pharmaceutical chemistry, neonatology,
pediatrics, immunology, veterinary science, complementary medicines and law.

32. GuidelinesV
Good Manufacturing Practices:-
• Guidelines on inspections involving the Gmp inspectors
• Isolator technology
• Penicillin manufacturing
• Radiopharmaceutical manufacturing
• Aerosol manufacturing
• Guidelines for preparation of site master file

33. Conclusion
• The Regulatory system for complementary medicines must
continue to ensure that the medicines having highest possible
level of confidence in their overall safety and quality.
• The current system of regulation of complementary
medicines allows consumers to have faith in the quality,
safety and efficacy of medicines.

34. 1. Kuchekar BS, Itkar SC, Forensic Pharmacy, fourth ed. Pune:
Nirali Prakashan, 2004,P. 306-332.
2. Jain NK, Pharmaceutical Product Development, Second ed.
NewDelhi:CBS Publishers and distributor, 2005,P.457:489.
3. Savant DA,The Pharmaceutical Sciences Pharma Pathway, Eighth
ed. Pune:Nirali Prakashan, 2010, P.2.103
REFERENCES

35. WEB REFERENCES
I. http://www.tga.gov.au
II. Australian regulatory guidelines for complementary
medicines<http://www.tga.gov.au/docs/html/argcm.htm
III. Australian regulatory guidelines for OTC medicines
<http://www.tga.gov.au/docs/html/argom.htm
IV. http://www.aboutus.org/Mhra
V. http://www.health.gov.za

36. THANKYOU