Consultation: Criteria for comparable overseas regulators

Enhanced international collaboration in the regulation of prescription medicines

31 October 2016

This consultation closed on 12 December 2016.

Invitation to comment

We are seeking comments from interested parties on proposed criteria to identify comparable overseas regulators (CORs) as providers of assessment reports and possible work-sharing partners in the assessment of medicine registration applications.

Consultation documents

How to access a pdf or Word document

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

The Expert Panel conducting the Review of Medicines and Medical Devices Regulation (MMDR) made recommendations aimed at streamlining the TGA's assessment and registration processes and improving timely access by Australian consumers to new medicines.

The MMDR review recommended that we make greater use of assessments from comparable overseas regulators (CORs) in our own processes. The MMDR review also recommended that we better utilise opportunities to work-share with CORs.

As part of both work-sharing and use of overseas assessment reports, we will continue to make the final regulatory decisions, ensuring that quality and safety are not compromised and that the Australian context is taken into account.

To ensure clarity and consistency in processes, we will develop and apply transparent criteria for identifying CORs. Consequently, this consultation expands on the draft criteria outlined in the MMDR recommendations and outlines how these would be applied within:

  • a process where a sponsor supplies a complete suite of COR assessment reports as part of a prescription medicine registration application and
  • a work-sharing process for applications simultaneously submitted to the TGA and a COR.

Submissions

We sought feedback on:

  • the proposed two-step process for identifying suitable opportunities for collaboration
  • the individual criteria for identifying a COR (Stage 1) and considerations that are taken into account when a submission or assessment report is received (Stage 2)

Enquiries

Any questions relating to submissions should be directed to the Reform Coordination and Support Section by email to MMDR.Consultation@tga.gov.au or by telephone to 02 6221 6884.

What will happen

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

We will review submissions and provide feedback through this website. Once finalised, the COR criteria 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.