Laws Governing Regulation of Medicines and Medical Devices in Australia
There are primarily two laws for regulation of medicines and medical devices in Australia:
- Therapeutic Goods Act, 1989
- Therapeutic Goods Regulations, 1990
The Therapeutic Goods Act 1989 (the Act) is the main legislation governing the regulation of therapeutic goods in Australia. The Act establishes the Therapeutic Goods Administration (TGA) as the regulatory body responsible for the regulation of therapeutic goods, including medicines, medical devices, and biologicals.
The major provisions of the Act include:
Definition of therapeutic goods: The Act defines therapeutic goods as any goods that are represented as being for therapeutic use and includes medicines, medical devices, and biologicals.
The Australian Register of Therapeutic Goods (ARTG): The Act establishes the ARTG, which is a register of all therapeutic goods that have been evaluated and approved for supply in Australia. The TGA is responsible for maintaining the ARTG.
Advertising of Therapeutic Goods: The Act regulates the advertising of therapeutic goods, including the requirement for advertising to be truthful, balanced, and not misleading.
Licensing of Manufacturers and Sponsors: The Act requires manufacturers and sponsors of therapeutic goods to hold a valid license or authorization issued by the TGA.
Surveillance and Enforcement: The Act provides for the surveillance and enforcement of therapeutic goods, including the power of the TGA to recall or prohibit the supply of therapeutic goods if they are found to be unsafe or not of good quality.
Penalties: The Act provides for penalties for breaches of the Act, including fines and imprisonment.
The Therapeutic Goods Regulations 1990 (the Regulations) are the secondary legislation that provide more detailed rules and procedures for the regulation of therapeutic goods in Australia under the Therapeutic Goods Act 1989. The Regulations provide additional provisions that supplement the Act, including the processes and procedures for the evaluation, registration and post-market surveillance of therapeutic goods, including medicines, medical devices, and biologicals.
The primary provisions of the Therapeutic Goods Regulations 1990 include:
Evaluation and Approval of Therapeutic Goods: The Regulations set out the processes and procedures for the evaluation and approval of therapeutic goods, including the requirements for submitting applications for inclusion in the Australian Register of Therapeutic Goods (ARTG), the criteria for evaluating the safety, quality and efficacy of therapeutic goods, and the conditions for the issuance of certificates of registration.
Post-market Surveillance: The Regulations provide for the post-market surveillance of therapeutic goods, including the requirement for manufacturers and sponsors to report adverse events and the power of the TGA to recall or prohibit the supply of therapeutic goods if they are found to be unsafe or not of good quality.
Advertising of Therapeutic Goods: The Regulations provide for the advertising of therapeutic goods, including the requirement for advertising to be truthful, balanced, and not misleading, and the provision of guidelines for the advertising of therapeutic goods.
Labelling and Packaging: The Regulations provide for the labelling and packaging of therapeutic goods, including the requirement for the provision of information on the label and packaging that is necessary for the safe use of the therapeutic goods.
Licensing of Manufacturers and Sponsors: The Regulations provide for the licensing of manufacturers and sponsors of therapeutic goods, including the requirement for manufacturers and sponsors to hold a valid license or authorization issued by the TGA and the provision of guidelines for the issuance of licenses.
Import and Export: The Regulations provide for the import and export of therapeutic goods, including the requirement for importers and exporters to hold a valid license or authorization issued by the TGA.
