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.