FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

TGA Issues New Criteria for Comparable Overseas Regulators

Jan. 8, 2018

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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