TGA seeks to clarify supporting evidence requirements for listed medicine indications
The Therapeutic Goods Administration has released a draft report which seeks to clarify the evidence required to support claimed therapeutic indications of listed medicines in Australia.
TGA evidence requirements clarified
The draft report entitled “Evidence required to support indications for listed medicines”, seeks to clarify the types, quality and quantity of evidence required to support claimed therapeutic indications of low risk non-registrable therapeutic goods (including most over-the-counter medicines and complementary medicines). Pursuant to the proposals, to secure an indication for a listed medicine in Australia, a sponsor must, amongst other things, substantiate the claimed indication by providing the TGA with an objective expert report that “contains a comprehensive analysis of the data relating to the proposed listable indication”.
Submissions due by 25 May
The TGA’s proposals are open for public consultation until 25 May 2012. Following this initial consultation period, the TGA will review submissions made by interested parties, and post its responses to the submissions on its website, with a view to publishing a revised report by July 2012.
The proposed reforms have arisen from recent reviews of the therapeutic goods regulatory regime in Australia, and the Australian Government’s response paper which was released in December 2011. The TGA intends that the revised report will replace the current “Guidelines for Levels and Kinds of Evidence to Support Indications and Claims for Non-Registrable Medicines, including Complementary Medicines and other Listable Medicines”, and be given legal effect through inclusion in the Therapeutic Goods Regulations.