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List of countries and jurisdictions determined to be comparable overseas regulators (CORs)

COR report-based process

24 October 2019

These are the countries and jurisdictions from whom the TGA will accept reports for use in the prescription medicines COR report-based process. This initial list has been determined by the Secretary for the purposes of subregulation 16DA(3) of the Therapeutic Goods Regulations 1990.

Country or Jurisdiction Regulatory Authority
Countries
Canada Health Canada
Japan Pharmaceuticals and Medical Devices Agency (PMDA)
Singapore Health Science Authority Singapore (HSA)
Switzerland SwissMedic
United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA)
United States Food and Drug Administration (FDA)
Jurisdictions
European Union European Medicines Agency (EMA) - centralised and decentralised processes

The application of the Stage 1 criteria to the above list was significantly informed by our existing involvement in several international initiatives aimed at reducing the duplication of work across agencies and convergence of medicines regulation through information-sharing and confidence-building.