Evidence required to support indications for Listed medicines (excluding sunscreens and disinfectants) – draft

On 13 July, the Therapeutic Goods Administration (TGA) released an overview of the consultation on the draft document ‘Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and disinfectants)’, which closed on 25 May 2012. The initial draft consultation aimed to clarify requirements for sponsors and improve the Australian community’s understanding of the TGA’s regulatory processes, thereby enhancing public trust in the safety and quality of therapeutic goods. Key features of the consultation document included: clear separation of scientific evidence and evidence of traditional use; guidance for sponsors about how to identify potential sources of evidence and how to assess evidence in terms of its relevance, quality, outcomes and consistency; a quantitative approach to the review process and where possible, algorithms have been provided for sponsors to assess different characteristics of evidence; a summary report template that must be completed and may be requested during listing compliance reviews; that the assessment of evidence should be undertaken by an individual with clinical and critical appraisal skills; and specific information (including a number of examples) relating to weight loss indications. On commencement of the consultation period, the TGA advised that it intended to embed the finalised document within the legislative framework for regulation of therapeutic goods in Australia. This reflected a recommendation of the Informal Working Group on Complementary Medicines and was agreed to in-principle by the Government in TGA Reforms: A blueprint for TGA’s future. The recent overview included: the submissions received the TGA’s response to a number of issues identified by respondents the next steps that the TGA will take in relation to the consultation. As advised on commencement of the consultation period, the TGA will provide feedback on the review and consideration of the submissions received in response to the consultation document. A summary of the broad issues identified from the submissions and the TGA’s response is now available. Currently, the TGA is considering the information received in the submissions and making arrangements to: adjust and finalise the consultation document develop an implementation plan to facilitate a phased approach to embedding the finalised document within the legislative

TGA, 13 July 2012 ;http://www.tga.gov.au/ ;