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TGA reforms: A blueprint for TGA's future
The TGA has a two-tiered regulatory framework for complementary medicines, based on risk. Low risk medicines containing pre-approved low risk ingredients with demonstrated safety and quality are listed on the ARTG. Evidence for efficacy for listed complementary medicines is not evaluated prior to entry, although sponsors are required to hold evidence to support their claims.
The TGA currently undertakes post-listing reviews of the evidence for a proportion of products listed each year through a targeted and random audit system. Higher risk complementary medicines must be registered on the ARTG, which involves individually evaluating the quality, safety and effectiveness of the product.
Applications for listed medicines are submitted through the TGA's Electronic Listing Facility. The Facility can detect and refuse to validate applications that are non-compliant with some, but not all, requirements. Following payment and subsequent inclusion of the listing on the ARTG, the medicine is eligible to be supplied into the Australian market.
Sponsors must, at the time of listing, certify that the medicine meets a range of requirements including the general requirements for the labelling of the product under the Act.
The Auditor-General's report into complementary medicines regulation highlighted:
- a poor rate of compliance with the regulatory requirements;
- a lack of incentives for sponsors to comply with the legislation;
- a lack of clarity and understanding of the regulatory requirements; and
- community concern that the labels of complementary medicines fail to inform consumers that listed medicines have not been assessed against efficacy criteria.
The flow-on effect of non-compliance with the regulations is a reduction in community confidence in the existing regulatory framework and the TGA's oversight of therapeutic goods more generally.
Further, the lack of understanding within the community of the TGA's regulatory role in this area has led to misconceptions around the level of regulatory rigour that complementary medicine products undergo. There has been reported confusion surrounding the 'AUST L' number, which must be printed on the label of listed complementary medicines to demonstrate that they have been listed on the ARTG.
Progress to 31 December 2014
Progress in implementing the Blueprint recommendations is provided in TGA Reforms: A blueprint for TGA's future Progress Report as at 31 December 2014. This report provides details of progress against the 48 recommendations to be implemented by the TGA during the four year program. In addition, the report highlights the expected benefits for Complementary medicines.
Progress of remaining Blueprint recommendations
In October 2014, the Australian Government announced the Expert Review of Medicines and Medical Devices Regulation (Expert Review). Progress of some reforms proposed in the Blueprint is dependent on the outcome of the Expert Review and the Government's response to the findings.