DRC Profile Updated
The DRC profile in ClinRegs has been reviewed and updated with the following information:
- Clinical trial application requirements and form for the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) (See Scope of Assessment, Scope of Review, the Clinical Trial Lifecycle topic, Site/Investigator Selection, Insurance & Compensation, Documentation Requirements, and the Investigational Products topic)
- ACOREP clinical trial application fees and payment instructions (See Regulatory Fees)
Sources Added During this Update:
(Order) Ministerial Order No. 1250/CAB/MSPHP/058/CJ/OBK/2023 Establishing the Procedures for Authorization, Marketing, Importation and Quality Control Fees for Medicines for the Benefit of the Congolese Pharmaceutical Regulatory Authority, ACOREP (Order1250-MSPHP058 - French) (November 16, 2023)
Ministry of Health
(Circular) Circular Note No. 0349/ACRP/DG/P/2024 Concerning the Procedures for Collection of Authorization, Marketing, Importation and Quality Control Fees for Medicines for the Benefit of ACOPEP, Defined by Ministerial Order No. 1250/CAB/MIN/SPHP/CJ/2023/058 of November 16, 2023 (Circular0349 - French) (May 8, 2024)
Ministry of Health
(Regulation) Requirements for an Application for Authorization of a Clinical Trial No. 0485/ACRP/CAB/DG/D15/2025 (AppAuthCTReqs - French) (May 13, 2025)
Congolese Pharmaceutical Regulatory Authority
(Form) Clinical Trial Application Form No. 0570/ACRP/DG/CAB/D15/2025 (DRC-17 - French) (May 29, 2025)
Congolese Pharmaceutical Regulatory Authority