FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

TGA Issues New Criteria for Comparable Overseas Regulators

Jan. 8, 2018
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Australia’s Therapeutic Goods Administration issued revised guidelines for its comparable overseas regulators (CORs) program, designed to collaboratively regulate prescription medicines using an international report-based process.

The following countries and jurisdictions are considered eligible to participate in the program under the revised criteria:

  • Canada (Health Canada);
  • Singapore (Health Science Authority Singapore);
  • Switzerland (SwissMedic);
  • The United Kingdom (Medicines and Healthcare products Regulatory Agency);
  • The United States (Food and Drug Administration); and
  • The European Union (European Medicines Agency).

The documentation requirements vary according to the jurisdiction.

The COR criteria are applied in two stages. Stage 1 uses preliminary criteria to confirm similarities between the TGA and the overseas regulator. Stage 2 focuses on the specific aspects of the particular application.

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