Safety & Regulation

Table of Contents

Safety and Regulation of Australian Complementary Medicines

Australia ensures the safety and regulation of complementary medicines through a robust regulatory framework overseen by the Therapeutic Goods Administration (TGA), part of the Australian Government Department of Health. The key components of this regulatory system include:

Therapeutic Goods Act 1989

The foundation of the regulatory framework for therapeutic goods in Australia, including complementary medicines. It establishes the legislative basis for regulating, licensing and monitoring these products.

Therapeutic Goods Administration (TGA)

The TGA is responsible for the assessment, registration, and monitoring of therapeutic goods, including complementary medicines. The TGA evaluates these products’ safety, quality, and efficacy before they are allowed to be sold in Australia.

Australian Register of Therapeutic Goods (ARTG)

Complementary medicines must be listed or registered on the ARTG before being legally sold in Australia. The TGA assesses each product’s formulation, labelling, and evidence of efficacy before inclusion on the register.

Good Manufacturing Practice (GMP)

Manufacturers of complementary medicines must adhere to GMP standards, ensuring product quality and safety. Regular inspections are conducted by the TGA to verify compliance.

Labelling Requirements

Complementary medicines must comply with strict labelling requirements, providing accurate and clear information for consumers. This includes information on the active ingredients, recommended dosage, and potential side effects.

Post-Market Monitoring

The TGA continues to monitor the safety of complementary medicines once they are on the market. Adverse events, product complaints, and other issues are investigated, and products can be removed from the market if safety concerns arise.

Advertising Controls

Advertising therapeutic goods, including complementary medicines, is regulated to ensure that claims made are accurate and not misleading. The TGA monitors and takes action against non-compliance.

Compliance and Enforcement

The TGA has the authority to take regulatory action against companies that do not comply with regulatory requirements, including fines and product recalls. This enforcement ensures accountability in the industry.

Overall, Australia’s regulatory framework for complementary medicines aims to balance the availability of these products with ensuring their safety, quality, and efficacy. The TGA’s ongoing monitoring and enforcement efforts contribute to maintaining the market’s integrity and protecting public health.