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Over-the-counter medicines reform

25 June 2012

The Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), are reviewing the business processes for the evaluation of over-the-counter (OTC) medicine registration applications, to reform the current system and develop a common approach in both countries.

The project is one of five 'Business-to-Business' projects being undertaken by Medsafe and TGA, as both agencies move to become a joint regulatory agency with the establishment of the Australia New Zealand Therapeutic Products Agency (ANZTPA) over the next four years.

The reforms are expected to:

  • deliver more efficient and effective processes
  • improve the quality of OTC medicine applications lodged with Medsafe and TGA
  • provide sponsors of OTC medicines with greater clarity, transparency and predictability
  • ensure that a process with an appropriate risk benefit model is used for market authorisation of OTC medicines
  • enhance the transparency of decision making for OTC medicine applications.

A CEO Forum and a Working Group, comprised of industry representatives from Australia and New Zealand as well as Medsafe and TGA representatives, and consumers has been established to develop improved processes for evaluation of OTC medicines.

Public consultation will take place when the revised processes have been better defined.


Following the signing of a Statement of Intent by the Australian and New Zealand Prime Ministers in June 2011, to establish the ANZTPA, Medsafe and TGA were asked to identify a series of projects which would deliver early benefits to consumers, health practitioners and the pharmaceutical industry. All parties agreed that, along with several other projects, there were significant benefits to be achieved by reforming the market authorisation processes for OTC medicines.

It is proposed that a streamlined risk based approach to market authorisation processes, together with more rigorous pre-application requirements and fixed company response times, would improve the processes in both countries. The level of assessment for an application for an OTC medicine will be determined based on a risk categorisation framework with 'minimal' data requirements, and assessment timeframes for products with well established efficacy and a long history of safe use, to a full assessment of the quality, safety and efficacy of any new active ingredient combinations.

Review of the OTC medicines evaluation processes provides an ideal opportunity for Medsafe and TGA to collaborate in the development of a harmonised approach. It is anticipated that harmonisation projects of this nature will provide valuable information and momentum towards establishing a trans-Tasman agency.