Consultation: Expedited pathways for prescription medicines

Eligibility criteria and designation process

31 October 2016

This consultation closed on 12 December 2016.

Invitation to comment

We sought comments from interested parties on two new expedited pathways (Priority Review and Provisional Approval) for the registration of prescription medicines that address unmet clinical needs for Australian consumers.

Priority Review will involve faster assessment of prescription medicines with a full data dossier in certain circumstances, allowing consumers with serious and life-threatening conditions to access these medicines more quickly if the assessment results in a decision to register the goods.

Provisional Approval will provide earlier access to certain promising new medicines that do not yet have a full dossier of clinical data, but where there is the potential for a substantial benefit to Australian consumers through the earlier availability of these medicines.

Comments are being sought on the proposed eligibility criteria and the process for determining that a medicine meets the eligibility criteria (designation process) for the two expedited pathways.

Consultation documents

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Timetable

Document released for consultation on Monday 31 October 2016.

Interested parties should respond by close of business on Monday 12 December 2016.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

We are developing two new expedited pathways for the registration of prescription medicines (Priority Review and Provisional Approval), in response to recommendations of the Review of Medicines and Medical Devices Regulation (MMDR review).

The purpose of this consultation is to provide an opportunity for consumers, health professionals and industry to contribute to developing the expedited pathways for prescription medicines, to ensure that implementation of these reforms will maintain timely and sustainable access to medicines for all Australians.

To highlight the similarities and differences between the expedited pathways, Priority Review and Provisional Approval of prescription medicines have been addressed together in this consultation. The scope of this consultation includes two elements that are common to both expedited pathways: the eligibility criteria and the designation process.

This consultation represents the first stage of our public consultation on the expedited pathways. Further public consultation on the details of the Provisional Approval pathway will occur in early 2017. We will work with industry to develop business processes and guidance documents to support the implementation of the Priority Review and Provisional Approval pathways.

Background

In March 2015, the Review of Medicines and Medical Devices Regulation (MMDR review) made recommendations aimed at streamlining the TGA's registration processes and improving timely access by Australian consumers to new medicines and medical devices.

Specifically, the MMDR review recommended that we implement expedited pathways for the registration of promising new medicines that address unmet clinical need in certain circumstances. Entry into these pathways is to be based on transparent eligibility criteria that are consistent with those adopted by comparable overseas regulators.

Content of submissions

We sought feedback on the proposed eligibility criteria and designation process outlined in the consultation paper. Submissions may address any, or all of the questions within the paper, as well as any other relevant issues (noting that further public consultation on the details of the Provisional Approval pathway is scheduled for 2017).

Enquiries

Any questions relating to submissions should be directed to the Policy and Reform Facilitation Section, Prescription Medicines Authorisation Branch by email to MMDR.Consultation@tga.gov.au or by telephone to our information line on 1800 020 653.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website. Once finalised, the eligibility criteria and designation process for Priority Review and Provisional Approval will be included in guidance material which will be published on the TGA website.

We are currently considering all submissions that were received as part of this consultation. We thank those who took the time to make a submission and to make comments and suggestions.

The TGA is committed to publishing consultation outcomes and submissions within a reasonable timeframe.

Further information will be provided as it becomes available.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.

Further information

Further information on the Government's response to the MMDR recommendations is available at: Medicines and medical devices regulation review.