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Reforms to the generic medicine market authorisation process: implementation update

17 December 2019

In early 2019, we consulted on proposed reforms to the generic medicine market authorisation process. In response to the feedback received, we have implemented the following changes:

  • Reduced requirements for use of overseas reference products in bioequivalence studies.
  • Options to use new internationally aligned templates for summarising bioequivalence or biowaiver study data.

Overseas reference products and bioequivalence studies

The requirements to establish 'identicality' between an overseas reference product and the Australian reference product have changed. Applicants:

  • no longer need to provide quantitative analysis of excipients for most solid oral dosage forms
  • can use the new flow chart and checklist to help determine what evidence is needed.

These changes come into effect immediately. All new applications will be evaluated in accordance with the new requirements. Any additional data provided in line with previous requirements will be considered supporting information.

See revised Guidance 15.6 - 'Choice of the reference product for bioequivalence of generic medicines' for more information.

Internationally aligned templates for summarising bioequivalence or biowaiver study data

New templates are now available to summarise bioequivalence related data:

  • Bioequivalence Study Information Form (BSIF)
  • Additional strengths biowaiver template
  • Biopharmaceutics Classification System (BCS)-based biowaiver template

The templates are the result of collaborations with other regulators internationally and are equivalent to similar templates developed by our comparable overseas regulators.

Applicants can choose to use these templates to prepare bioequivalence evidence and reduce the risk of submitting incomplete dossiers. If you use these templates in your application, this may also remove the need to submit other information in other sections of the dossier.

See Bioequivalence data summary templates for more information.

In-progress reforms

In early 2019 we also consulted on a proposed new process for providing early advice from the TGA on biowaiver justifications. Amendments to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 are needed to implement the new process and are being progressed.