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Australia – Revised And Restructured Guidelines For Complementary Medicines Released.

22 April, 2014

 


What You Need To Know

 

  • The revised Australian Regulatory Guidelines for Complementary Medicines are now available from the TGA website.
  • The consolidated document incorporates comments received on Parts A, B, C and D through the Therapeutic Goods Administration’s (TGA) consultation process. The TGA has also published its responses to the submissions received.
  • The revised ARGCM do not introduce any new procedures or procedural changes, but rather have amended outdated information to reflect current regulatory practice.

 
On 16 December 2013, the TGA published its responses to submissions received as part of its consultation on the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).

 
The revised and updated ARGCM are now available on the TGA’s website.

 
Revised ARGCM

 
The revised ARGCM are structured into four parts, with Attachments containing technical information:

 

  • Part A: General guidance on complementary medicine regulation in Australia provides an overview of the regulatory framework for therapeutic goods in Australia. It includes information about different types of complementary medicines, the difference between active ingredients and excipients and the interface between foods and medicines.
  • Part B: Listed complementary medicines covers the regulatory requirements for listed complementary medicines.
  • Part C: New complementary medicine substance evaluation covers the evaluation process for new complementary substances to be approved.
  • Part D: Registered complementary medicines covers the regulatory requirements for registered complementary medicines.

 
The revised ARGCM are part of a broader package of reforms to the TGA and regulation of complementary medicines in Australia following the Auditor-General’s recommendations on the ANAO audit of TGA regulation of complementary medicines in August 2011. The purpose of the revised ARGCM is to make sure they are consistent with current legislation and practices and to increase their usability.

 
The consultation process began in October 2012, when the draft of Part A was released for comment. Drafts of Parts B, C and D were subsequently released and each section was subject to a four week consultation period. Submissions closed for Part D in July 2013.

 
Submissions

 
The TGA received submissions from organisations such as the Australian Self-Medication Industry, the Complimentary Healthcare Council of Australia, Consumers’ Health Forum, the Pharmacy Guild of Australia and the Dieticians Association of Australia. All submissions not marked as confidential are now available at http://www.tga.gov.au/newsroom/consult-cm-argcm-submissions.htm“. A total of 27 submissions were received.

 
Further Revision

 
The TGA has reported that all submissions it received supported the revision and restructure of the ARGCM. Although the consolidated document is now available online, the TGA will continue to receive comments on any part of the document via its website. It has explained that further revision will occur as needed. Given that the revised ARGCM is a complete rewrite of the original ARGCM, the TGA has advised that it will not produce a change log indicating what revisions have been made. Any further changes, however, will be indicated on the website.

 

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For further information, please contact:

 

Grant Fisher, Partner, Ashurst
grant.fisher@ashurst.com


Katherine Payne
katherine.payne@ashurst.com

 

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