tga, mhra, mcc, mca

05/01/2023 Sagar Savale 1

REGULATORY AUTHORITIES TGA, MHRA, MCC, MCA

Mr. Sagar Kishor savale[Department of Pharmaceutics] [email protected]

Department of Pharmacy (Pharmaceutics) | Sagar savale


Contents

1. Introduction

2. History

3. Regulatory Program

4. Organization/Governance

5. Guidelines

6. Conclusion

7. References


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.


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.


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.


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•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.


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.


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).


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.


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.


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).


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.


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.


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.


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.


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


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.


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.


• 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.


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


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


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.


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• 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.


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.


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.


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.


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


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.


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• 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.


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• 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.


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


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.


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


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


THANK YOU

tga, mhra, mcc, mca

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