Mali Profile Updated

The Mali profile in ClinRegs has been reviewed and updated with the following information:

• Additional statement related to health inspectors, the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)), and approved ethics committee (EC) members ensuring compliance with biomedical research legislation (See Scope of Assessment and Scope of Review)
• Updated list of ethics committees (ECs) that comprise Mali’s EC system to include the Ethics Committee of the National Office for Reproductive Health (Comite D'Ethique De L'Office National De La Sante De La Reproduction (ONASR)) (See Ethics Committee)
• Statements throughout the profile indicating that ECs and researchers in Mali are required to comply with the ICH Harmonised Guideline for Good Clinical Practice E6(R3)

Sources Added During this Update:

(Regulation) Decision No. 2024-0000992/MSDS-SG of May 3, 2024 - Establishing the Ethics Committee of the National Office for Reproductive Health (ONASR) (D-No2024-0000992 - French) (May 3, 2024)
Ministry of Health and Social Development

(International Guidance) ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3) (MLI-5) (January 6, 2025)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Sources Revised During this Update:

(Not Available Online) NIAID Correspondence with the CIESS/USTTB (December 2025) (MLI-17)