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Submissions received in response to: Consultation: Criteria for comparable overseas regulators

24 July 2017

Enhanced international collaboration in the regulation of prescription medicines

Between 31 October and 12 December 2016, the TGA sought 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 prescription medicine registration applications.

We thank those individuals and organisations for their valuable feedback.

We plan to publish the final COR criteria and details about the process for using COR assessment reports in prescription medicines applications by the end of 2017.

Submissions received

All submissions that were not marked as confidential are now available in PDF format. The list below also includes those who consented to their name (but not their submission) being published on the TGA website.

Further information

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