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TGA post market regulatory activity of complementary medicines
ARGCM Part A: General guidance on complementary medicine regulation in Australia
We monitor the continuing safety, quality and efficacy of therapeutic goods in the market through therapeutic product vigilance activities. We adopt a risk management approach to regulating therapeutic goods. Information on our approach to managing compliance risk is available at: TGA regulatory framework.
The types of post market regulatory activities include the following.
Adverse events reporting for complementary medicines
We receive reports of adverse events from consumers, health professionals, the pharmaceutical industry, international medicines regulators or by medical and scientific experts on TGA advisory committees.
If you experience an adverse event to a complementary medicine, you should seek advice from a health professional and then report the adverse event to the TGA.
Section 29A of the Act requires sponsors of medicines registered or listed in ARTG to report adverse reactions about which they become aware. Guidance for sponsors is provided in Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines.
Inspection of manufacturers
Manufacturers of therapeutic goods supplied in Australia are subject to regular inspections for compliance with good manufacturing practice. Details of the requirements for the manufacture of medicines are specified in the PIC/S Guide for Good Manufacturing Practice for Medicinal Products. For more information regarding the GMP inspection of medicine manufacturers please refer to Manufacturer inspections - an overview.
Sampling of medicines in the marketplace for testing
We undertake a laboratory testing program which complements the desk-based compliance reviews of listed complementary medicines and evaluation of registered medicines, as well as other post market regulatory activities. The laboratory testing program prioritises therapeutic goods considered to carry a higher risk, while still allowing for responsive testing for issues arising in the marketplace, for example: adverse events and complaints about specific medicines. For more information on the laboratory testing program, refer to the Laboratories Branch activities.
Compliance reviews of listed complementary medicines
The regulatory process for listed complementary medicines allows for early market access for low-risk complementary medicines. In facilitating early market access, there is reliance on a comprehensive risk-based system of post market monitoring. We review a proportion of listed complementary medicines for compliance with the regulatory requirements. These reviews may be:
- random reviews: a proportion of newly listed medicines are randomly selected by computer; or
- targeted reviews of listed medicines identified with potential non-compliance issues.
For more information on the random and targeted compliance reviews, including possible regulatory actions and appeal rights, refer to Listed complementary medicine compliance reviews.
Cancellations from the ARTG following compliance review are routinely published on our website.
Further to the product compliance reviews described above, specific safety and efficacy reviews in response to issues arising in the market place may be carried out for:
- individual medicines
- medicine groups.
Product recalls of therapeutic goods
A product recall is the removal of therapeutic goods from supply on the Australian market for reasons relating to their quality, efficacy or safety. Recall of any distributed goods is required whenever public safety is at risk as a result of product noncompliance. A recall can occur because of problems such as: labelling or packaging errors; contamination issues; or an increase in unexpected side effects. Further information on recalls of therapeutic goods is provided on our website: About recall actions.