Guided By:Mr. Jigar ShahPrepared By: Tushar Bambharoliya

Institute of PharmacyNiRMA UNIVERSITY

TGA (Therapeutic Goods Administration,

Australia)

What is TGA ?

• Therapeutic Goods Administration, which came into effect on 15 February 1991

• 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

• 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.

• Essentially therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia

What is a therapeutic good ?

• A '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)

What the TGA does• The TGA carries out a range of assessment and monitoring activities to ensure

therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.

1. Regulation of therapeutic goods in Australia The regulatory framework is based on a risk management approach designed to ensure

public health and safety, while at the same time freeing industry from any unnecessary regulatory burden

2. A history of therapeutic goods regulation in Australia Publication capturing the long history of the evolution of therapeutic products

regulation in Australia3. Australian register of therapeutic goods (ARTG)

What it is and how to view it4. Medicines regulation and the TGA

A general introduction to the regulatory process for medicines in Australia5. The TGA's risk management approach

Describes the TGA's role in the management of risks associated with medicines, medical devices, blood and tissues

6. TGA NewsNewsletter produced 3 times a year

Therapeutic Goods Administration organisational structure

• National Manager: Dr Rohan Hammett• Principal Medical Adviser: Dr Ruth Lopert– Business Management Group– Executive Support Unit– Office of Complementary Medicines– Office of Devices, Blood and Tissues– Office of Laboratories and Scientific Services– Office of Manufacturing Quality– Office of Medicines Safety Monitoring– Office of Non Prescription Medicines– Office of Prescription Medicines

Regulations by TGA Regulates medicines -Prescription medicine products -Complementary medicines -Disinfectants -OTC products

Regulates tissue, blood & blood products

Regulates medical devices

Post marketing vigilance

Complementary medicines (TGA)

Herbs Nutritional supplements

Ayurvedic Medicines

Traditional Chinese

Medicines

Homoeopathic medicines Vitamins

MineralsAromatherapy products

Other Traditional Medicines

• TGA has developed the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) to assist sponsors of complementary medicines to meet their legislative obligations

• 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

Regulatory guidelines & standards• The regulation of complementary medicines in Australia - an overview• Australian regulatory guidelines for complementary medicines (ARGCM)• Ingredients/excipients• Compositional guidelines• Enforcement guidelines• Specific products/substances• Approved terminology for medicines• Section 7 declarations - food or therapeutic good?• Guidelines for levels and kinds of evidence to support indications and

claims• European Union guidelines• Pharmacovigilance & reporting adverse drug reactions• How do I determine whether my product is a therapeutic product?

For complimentary medicines TGA developed 1. Safety of ingredients for use in Listed

complementary medicines

2. Quality standards for ingredients for use in Listed complementary medicines

-British Pharmacopoeia (BP) is currently the source of official standards, The BP is supplemented by Therapeutic Goods Orders (TGOs)

3. Efficacy of Listed complementary medicines -The indications and claims are true, valid

and not misleading -TGA has developed the Guidelines for levels

and kinds of evidence to support indications and claims to assist sponsors in determining the level of evidence required to support indications and claims made for complementary medicines.

Adverse drug reaction reporting :

-Australian 'Blue Card' scheme covers all medicines and most health professionals

-Publication of a report in the Australian Adverse Drug Reactions Bulletin or medical journals to raise awareness of the reaction and/or removal of the product from the market

Advertising

-Therapeutic goods in Australia is subject to the advertising requirements of the Act (which adopts the Therapeutic Goods Advertising Code [TGAC] 2005) and the supporting Regulations, the Trade Practices Act 1974 and other relevant laws.

Regulation of prescription medicines

• Include a new medicine in the ARTG applicable to medicines that are evaluated by the Drug Safety and Evaluation Branch (DSEB) of the TGA

• CTD format for the documentation of data on the quality, non-clinical and clinical aspects of medicines

Guidelines related to prescription medicines given under

• Module 1: Administrative Information and Prescribing Information For Australia and

• Volume 2B: Notice to Applicants: Medicinal products for human use, Presentation and format of the dossier CTD

Regulation of Disinfectants & Sterilants

• Therapeutic Goods Order No 54 - Standard for Disinfectants and Sterilants (TGO 54)

• Registrable goods : -sterilants, instrument grade disinfectants, and

hospital or household/commercial grade disinfectants

For sterilants and instrument grade disinfectants:

• commercial history, regulatory actions and regulatory status•evidence of GMP compliance of overseas

manufacturers/licensing of Australian manufacturers may be required at a later date.

• risk analysis• formulation and physical/chemical properties including stability• microbial efficacy• toxicity/residues• effects of sterilant or disinfectant on devices• container/packaging• labelling

• For hospital grade disinfectants with claims or household/commercial disinfectants

• microbial efficacy (as relevant to specific claims)

• formulation • container packaging (materials related only)• labelling

Regulation of blood

Under the Act 'blood' means whole blood extracted from human donors and 'blood components' means therapeutic components that have been manufactured from blood (including red cells, white cells, progenitor cells, platelets and plasma)

Blood and blood components and plasma must be manufactured in compliance with the Australian Code of GMP for Human Blood and Tissues

• Therapeutic Goods Order 75 Standards for Haematopoietic Progenitor Cells Derived from Cord Blood states that haematopoietic progenitor cells derived from cord blood must meet the requirements of the document entitled'International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection, and Release' published by the Foundation for the Accreditation of Cellular Therapy and NetCord and must be appropriately screened for HIV

Human tissue for implantation in the human body that is obtained, stored and supplied without any deliberate alteration to its biological and mechanical properties must comply with the Australian Code of Good Manufacturing Practice, Human Blood and Tissues

Includes most banked tissue, such as Dura mater, heart valves, skin, corneas and bone.

Regulation of tissues

Human derived tissue and cell products that

• Are not regulated as medicines; and• Are produced by deliberate alteration of tissue or cells in

defined manufacturing processes

are being regulated as "therapeutic devices" and declared other therapeutic goods (OTGs) by Therapeutic Goods (Articles that are not Medical Devices)

• Defined in the legislation as “any instrument, apparatus, appliance, material or other article intended by the person under whose name it is to be supplied, to be used for human beings for the purposes of

• Diagnosis, prevention, monitoring, treatment or alleviation of disease

Medical devices

Office of Devices, Blood and Tissues (ODBT) is the area within the TGA responsible for regulating medical devices

Medical Devices Evaluation Committee (MDEC) which provides advice to the Minister on issues relating to the safety, quality, performance and timely availability of medical devices

Classification of Medical Devices based on: - Manufacturer’s intended use - Level of risk; and - Degree of invasiveness in the human body

Classification of medical devices:

Class I Class IIa Class IIb Class III Active Implantable Medical Devices (AIMD)

• Few examples are : -Beds (class I) -Anaesthetic Breathing circuits (class IIa) -Dental filling materials (class IIa) -Anaesthetic machines (class IIb) -Apnea monitors (class IIb) -Absorbable sutures (class III) -Breast implants (class III) -Implantable drug infusion devices (AIMD) -Implantable pulse generator (AIMD)

• Higher class devices undergo a more stringent form of conformity assessment than lower class devices

• Certification by the TGA or an overseas notified body is required for higher risk devices

To maintain consumer confidence in the quality, safety and effectiveness of medicines supplied in Australia

Targeted and random laboratory testing of products and ingredients

Targeted and random surveillance in the market place

An effective, responsive and timely recalls procedure

Post marketing vigillence

• Audit of GMP

• Targeted and random desk-based audits of Listed products

• Monitoring of adverse reactions to complementary medicines

• Effective controls for the advertising of therapeutic goods

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REFERENCES