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Submissions received: Whether the TGA should publish that a prescription medicine is under evaluation

8 April 2020

Between 15 February and 29 March 2019, the TGA sought comments from interested parties on the public consultation paper "Whether the TGA should publish that a prescription medicine is under evaluation".

A total of 39 submissions were received from industry, health professionals, consumer representative groups, regulatory consultants and government.

Submissions received

We thank individuals and organisations for their submission and valuable feedback. All submissions that were not marked as confidential are now available in PDF format.

How to access a pdf document

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A further five submissions were received with claims of confidentiality or privacy that prevent the publication of the submissions and the identities of those providing submissions.

Response and next steps

The Australian Government has given approval to proceed with implementation of enhanced transparency measures for prescription medicines, in response to public demand for more information on prescription medicines that are under evaluation. Two measures are proposed:

  • Measure 1: Early publication of major innovator medicine applications: This measure will introduce earlier publication of major innovator prescription medicines that have been accepted for evaluation under section 25 of the Act. The measure will provide information on potential availability of new medicines, or new uses for medicines and new combinations (where one active ingredient is a new medicine). Publication will occur from June 2020.
  • Measure 2: Earlier notification of generic medicine applications to the innovator: This measure will introduce earlier notification of generic medicine applications to the innovator. Implementation is planned for early 2021.

The TGA is seeking feedback from sponsors on implementation options for these measures, commencing 27 March and ending 9 June 2020.

Documents

How to access a pdf or Word document

Enquiries

Questions relating to these measures should be directed to the Application and Advisory Management Section by email to: info@tga.gov.au.