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Australia plans reform of its generics authorization process Posted 01/03/2019

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), announced on 7 February 2019 a public consultation into proposed improvements to its generics authorization process.

The agency is considering a range of options to improve the way the TGA authorizes generics in Australia.

One of these options is to allow the use of reference products from other countries in bioequivalence studies. Currently, the reference product used in such studies has to be medicine approved in Australia. On this issue the TGA says that its ‘requirements are largely consistent with comparable overseas regulatory agencies, such as those in Europe and Canada. However, some agencies, such as those in Switzerland and Singapore, do not always rely on the same way of demonstrating ‘identicality’. Under certain conditions, there is less emphasis placed on confirming the exact quantities of the non-active ingredients’. The agency is therefore ‘investigating whether similar approaches could also be applied in Australia’.

Another option is to introduce incentives to encourage applications for new generics of ‘special interest’, especially in cases where there are medicine shortages.

The agency is also exploring the use of international templates to improve opportunities for joint submissions to multiple agencies.

The agency wants to introduce the reforms in order to:
• reduce regulatory barriers for applicants seeking to register generics, while maintaining existing safety, quality and efficacy standards
• make the application process easier by making regulatory requirements clearer and more transparent
• support international work sharing opportunities
• provide incentives for specific generics applications, where these would support a more robust supply of medicines.

The TGA is seeking feedback and suggestions on these options and the consultation is open for comment until 21 March 2019. Comments can be submitted online via the TGA website or alternatively hardcopy submissions can be mailed to: Scientific Operations Management Section, Scientific Evaluation Branch, TGA, PO Box 100, Woden Act 2606, Australia.

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Source: TGA

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