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Consultation: Evidence required to support indications for Listed medicines (excluding sunscreens and disinfectants)
This consultation closed on 25 May 2012. A revised version of the evidence requirements document was released for further consultation on 27 August 2012.
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Written submissions were invited on the following document:
- Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and disinfectants) - draft (pdf,895kb)
- Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and disinfectants) - draft (docx,3.24Mb)
As advised on commencement of the consultation period, submissions lodged in response to the consultation document will be placed on the TGA's website, unless marked confidential. The public submissions received for this consultation have now been published.
TGA response to submissions
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.
What will happen
The TGA is now 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 framework for regulation of therapeutic goods in Australia.
On 23 April 2012, the TGA sought comments from interested parties on the draft of the document 'Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and disinfectants)' (the consultation document).
The consultation document 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. To achieve this, the consultation document:
- provided information to help sponsors of listed medicines to meet their obligations under therapeutic goods legislation; and
- ensured that applications to the TGA relating to listed medicines are supported by appropriate evidence.
The consultation document was based on, and intended to replace, the Guidelines for Levels and Kinds of Evidence to Support Indications and Claims for Non-Registerable Medicines, including Complementary Medicines and other Listable Medicines.
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.
Potential submitters were advised that they could address any, or all, aspects of the evidence document and other identified issues. It was also suggested that submitters might comment on their position on the document, suggested improvements, perceived impact on compliance with the regulatory framework and details regarding impact on commercial aspects of business.
Any questions relating to submissions should be directed, by email, to firstname.lastname@example.org.