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Consultation: Evidence required to support indications for listed medicines (excluding sunscreens and disinfectants)

27 August 2012

This consultation  opened on 27 August 2012 and closed on 22 October 2012.

Consultation documents

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Invitation to comment

The TGA sought comments from interested parties on proposed amendments to the Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and disinfectants)

Timetable

Document released for consultation on Monday 27 August 2012.

Interested parties responded by close of business Monday 22 October 2012.

Feedback will be released following consideration of submissions (see 'What will happen').

About the consultation

The TGA is currently developing a document 'Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and disinfectants) (Evidence Requirements). The document specifies the type of evidence required to support indications made for listed (low risk) medicines (including weight loss products) and is 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'.

In April 2012 the TGA consulted on the draft Evidence Requirements document. The TGA has considered the information received in submissions to the first consultation and has revised the draft Evidence Requirements. The revised document differs from the first consultation draft in several ways:

  • Information has been separated into two sections, Part A which includes evidence requirements for sponsors of listed medicines, and Part B which provides additional guidance regarding how these requirements may be achieved
  • The document now includes two routes for identification of evidence. Established sources of evidence for indications, such as comprehensive evidence reviews conducted by international regulators, will be considered adequate evidence in their own right. Full systematic reviews will be required to generate support for indications not included in these sources of established evidence
  • The requirement for an expert to conduct evidence reviews has been removed.

Taken together, these modifications introduce increased flexibility whilst ensuring that the review of evidence is performed appropriately. These modifications are also expected to markedly reduce any additional burden on industry.

The TGA sought input from industry on the revised Evidence Requirements. Feedback received through the consultation process will help inform a regulatory impact statement and assist the TGA to develop appropriate transitional arrangements for sponsor compliance when the final document comes into effect.

Background

This document has been developed in response to the Auditor-General's recommendations following the ANAO audit of TGA regulation of Complementary medicines and is part of the Complementary Medicines Regulatory Reforms package. The TGA intends to embed the document within the legislative framework for regulation of therapeutic goods in Australia. This reflects 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

Content of submissions

Specifically, the TGA sought:

  • an assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits; and
  • whether or not you support the revised Evidence Requirements.

In addition, submissions might include:

What will happen

Submissions were acknowledged as they were received.

At the completion of this consultation process, the TGA will collate and analyse submissions on matters that are within the scope of this review.

The TGA will finalise the Evidence Requirements and publish as per the time proposed time schedule.

Updates on progress of the review and expected timeframes will be provided on the TGA website.

If you would like to be kept informed on TGA reform consultation activities, please subscribe to the TGA-UPDATE email list.

Confidentiality

All submissions will be placed on the TGA website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

Enquiries

Any questions relating to submissions should be directed to ocm@tga.gov.au or by telephone to 1800 020 653 or 02 6232 8634.

If you would like to be kept informed about TGA activities, please subscribe to one of the TGA's email lists.

Submissions received

Submissions received in response to the consultation paper (apart from two submssions marked as confidential) are published below.

The TGA is currently considering the submissions. A TGA response to the submissions and the revised final document will be published in 2013.

How to access a pdf document

*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

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