Consultation: Provisional Approval pathway for prescription medicines

Proposed registration process and post-market requirements

1 September 2017

This consultation closed on 1 May 2017.

Invitation to comment

The TGA sought comments from interested parties on the proposed Provisional Approval registration process and post market requirements for provisionally registered medicines.

The public consultation paper sought written submissions from interested individuals and representatives from industry, consumer and health professional groups.

Consultation documents

How to access a pdf or Word document

Timetable

Documents released for consultation on Monday, 20 March 2017.

Interested parties responded by close of business Monday, 1 May 2017.

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

About the consultation

The purpose of this consultation is to:

  • Outline the objectives of the Provisional Approval pathway for prescription medicines being developed by the TGA
  • Seek feedback from consumers, health professionals and industry on key aspects of the proposed pre-market registration process; post-market requirements specific to provisionally registered medicines; and lapsing or transition to full registration.

The public consultation paper focuses on aspects of the Provisional Approval pathway that will inform the necessary legislation and regulation amendments for implementation. It will also inform further development of TGA business processes and guidance documents for sponsors, which will be finalised following targeted consultation with industry later in 2017.

The public consultation on the Provisional Approval registration processes and post-market requirements is being conducted at the same time as public consultation on the proposed enhanced Medicines Vigilance Framework. This will ensure that the two streams of reform are appropriately aligned and clearly communicated to industry, health professionals and public health advocates and consumers.

Background

The Australia Government agreed to the recommendations from The Review of Medicines and Medical Devices regulation (MMDR review) to implement expedited pathways, noting that legislative amendment will be required to implement the Provisional Approval pathway.

In October 2016, the TGA released a public consultation paper, Consultation: Expedited pathways for prescription medicines, on the proposed eligibility criteria and designation process for both of the expedited pathways (Priority Review and Provisional Approval). An overview of the outcomes of this consultation process is available at Submissions received: Expedited pathways for prescription medicines

The Provisional Approval pathway will allow sponsors to seek a time-limited provisional registration of certain promising new prescription medicines that do not meet our full clinical data requirements, where the potential benefit of earlier availability of the medicine outweighs the risk that additional data are still required. Sponsors will be required to collect and submit post-market safety and efficacy data before a decision about whether to grant the product full registration is made.

Content of submissions

We sought specific feedback on aspects of the Provisional Approval registration process (from pre-market registration applications through to automatic lapsing or full registration) and the proposed post-market requirements for provisionally registered medicines outlined in the consultation paper. Submissions may address any or all of the questions within the paper, as well as any other relevant issues.

What will happen

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise.

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Development of TGA business processes and guidance documents for sponsors will then be undertaken following targeted consultation with industry in late 2017. Once finalised, guidance material on the Provisional Approval pathway will be published on the TGA website.

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).
  • The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the online form).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
  • 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.

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.

More information

Further information on the Government's response to the MMDR recommendations is available at Medicines and Medical Devices Regulation review.

The 2016 public consultation paper on the eligibility criteria and designation process for both the expedited pathways is available at Consultation: Expedited pathways for prescription medicines.

A separate public consultation paper seeking comments on the implementation of a range of enhancements to the TGA medicines Vigilance Framework is available at Consultation: Strengthening monitoring of medicines in Australia.