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Consultation: ARGCM Part A: General guidance

Related information

10 October 2012

This consultation closed on 7 November 2012

The TGA sought comments from interested parties on the draft document Australian regulatory guidelines for complementary medicines (ARGCM) Part A: General guidance.

Consultation documents

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Timetable

Document released for consultation on 10 October 2012.

Interested parties should respond by close of business 7 November 2012.

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

About the consultation

The ARGCM provides information for manufacturers, sponsors, healthcare professionals and the general public on the legal arrangements for the supply and use of complementary medicines in Australia. The ARGCM was first published in 2001 and is comprised of Parts 1-5:

  • Part I - Registration of complementary medicines
  • Part II - Listed complementary medicines
  • Part III - Evaluation of complementary medicine substances
  • Part IV - General guidance
  • Part V - Policy documents and guidelines

The TGA is currently reviewing and restructuring the ARGCM to increase the useability of the guidelines and to ensure the information provided is reflective of current regulatory requirements. Changes to the original document include formatting, corrections, clarification and consolidation of information. The revised document does not introduce any new procedures or procedural changes.

The revised ARGCM has been restructured into four parts with technical information provided in Attachments.

  • Part A: Provides an overview of the regulatory framework for therapeutic goods in Australia. Information is provided on: the regulation of different types of complementary medicines; active and excipient ingredients; medicine terminology; exempt medicines; practitioner products; and medicine/ food interface issues.
  • Part B: Provides guidance on the regulatory framework for listed 'low risk' complementary medicines.
  • Part C: Provides guidance on the evaluation process for a new complementary substance to be approved for use in listed medicines.
  • Part D: Provides guidance on the registration process for complementary medicines.
  • Attachments: Provide technical details and requirements relevant to the procedural information provided in the main body of the document.

The TGA plans a staged approach to the consultation process for the revised ARGCM. Each draft part (A, B, C and D) will be published separately on the TGA website, with a 4 week consultation period provided for each part. Attachments will be published relevant to each part of the ARGCM.

Following consideration of submissions received, all parts will be consolidated into a final document reflective of the current regulatory requirements for complementary medicines.

In the future, the ARGCM will be revised as required when the proposed regulatory reforms for complementary medicines (as part of the 'TGA reforms: a blueprint for TGA's future') have been developed and implemented. Note that a further comprehensive consultation process will be provided when amendments to the ARGCM occur.

Background

This ARGCM is being reviewed and updated 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.

Content of submissions

Submissions might include:

  • Suggested improvements, amendments, corrections and areas requiring clarification in the Draft ARGCM Part A.
  • Comments on any other issues related to the review of the ARGCM.

What will happen

Submissions will be acknowledged as they are 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 ARGCM and publish as per the 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 general questions relating to submissions should be directed to ocm@tga.gov.au, using the subject line 'ARGCM Part A review'.

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