Regulatory Focus™ > News Articles > Australia's Overhaul of OTC Guidelines Attracts Industry Comments, Proposed Revisions

Australia's Overhaul of OTC Guidelines Attracts Industry Comments, Proposed Revisions

Posted 12 October 2012 | By Alexander Gaffney, RAC

Australia's Therapeutic Goods Administration (TGA) has released responses submitted to the agency regarding a draft guideline set to change the way the regulator oversees over-the-counter (OTC) medications.

The guidance, Australian regulatory guidelines for OTC medicines (ARGOM), was first published in 2003, and since then has only undergone two minor updates in early 2011.

In early 2012, TGA released a major planned update to the ARGOM, including the way it plans to assess the safety, efficacy, quality, presentation, applications and references of OTC medications submitted to the agency. The new ARGOM is also set to use a new content organization structure, which TGA said will, "allow for an easier process in updating ARGOM in the future."

Five industry submissions commenting on the proposed guidance were ultimately submitted, with the majority of comments either pertaining to ARGOM's sections on quality or specific OTC products.

For instance, "A number of respondents identified that there was insufficient guidance on medical devices that are used with OTC medicines, whether they are packaged together or separately supplied," TGA said. "Furthermore it was pointed out that the information provided was confusing and inaccurate and the examples given in the guideline did not appear to be consistent with ARGMD. It was proposed that the guideline should cite sections of the Australian Regulatory Guideline for Medical Devices (ARGMD) where appropriate."

The agency said it would work to revise the section.

Other comments said that quality information contained in the guidelines was "not as clear as the current document" in regard to licensing active ingredients, but TGA said it disagreed with this assessment and would not be making changes.

TGA said it would, however, amend the ARGOM's presentations section to provide more guidance on restricted representations relating to sponsorships of medicines and work to revise the guidance's section on toxicology, which comments called "unclear."

A final revision will be undertaken to "further clarify the requirements for paediatric products containing sedating antihistamines" and the use of cough and cold medicines, the use of which TGA recently restricted.

Comments on the draft guidance were submitted by Accord Australasia, the Australian Self Medication Industry (ASMI), Bayer Consumer Care, Consumers Health Forum Australia (CHFA) and the Locus Consulting Party. Other stakeholders, including the Generic Medicines Industry Association of Australia and Medicines Australia were invited to comment, but it is unclear whether they did.


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