Approval of clinical trials

The approval of clinical studies in Bulgaria is a consecutive process in 2 steps:

1. Approval by Local Ethics Committees (LEC) - 30 days;
2. Approval by the Competent Authority (CA) which in Bulgaria is the Specialised Commission for the approval of Clinical Trials belonging to the Ministry of Health - 60 days

All approvals from relevant Local Ethics Committees should have been obtained before applying to the Competent Authority.

The whole approval process takes around 100 days.

The following documents are required by both the LECs and the CA:

1. Protocol signed by the Principal Investigator;
2. Case Report Form;
3. Investigators Brochure;
4. Written Patient Information and Consent Form in local language;
5. CV of the Principal Investigator;
6. Certificate of analysis of the study drug;
7. GMP Certificate;
8. Study drug labels in local language.

Bulgarian Drug Agency

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