The State Agency of Medicines provided the European Commission with the requested documentation and evidence, demonstrating that the national legislative framework and operational practices enable the effective planning, execution, and oversight of clinical trial inspections.
Inspectors are duly qualified, independent, and vested with sufficient authority to verify compliance with GCP requirements. All inspections are systematically documented and registered in the EU Clinical Trials Information System (CTIS).
The audit outcomes confirm that Estonia has an established and sustainable strategy to ensure the quality of clinical trials and conformity with Good Clinical Practice standards. The consolidated results of the European Commission review will be published progressively in the CTIS database.
