Mali Profile Updated

The Mali profile in ClinRegs has been reviewed and updated as follows:

New Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) clinical trial application form providing submission documentation requirements (See Scope of Assessment, Regulatory Fees, the Clinical Trial Lifecycle topic, Insurance & Compensation, and Manufacturing & Import)
Procedures for implementing pharmacovigilance via Mali’s National Pharmacovigilance System (See Safety Reporting)

Sources Added During this Update:

(Legislation) Law No. 01-040/of June 7, 2001 – Ratifying Order No.00-039/P-RM of September 20, 2000 Creating the Pharmacy and Medicines Directorate (LawNo01-040 - French) (June 7, 2001)
Republic of Mali

(Order) Order No. 2011-4201/MS-SG OF 14 October 2011 - Setting the Methods for Implementing Pharmacovigilance (OrderNo2011-4201 - French) (October 14, 2011)
Ministry of Health

(Form) Application Form for Clinical Trial Authorization in Mali (MLI-1 - French) (Date Unavailable)
Directorate of Pharmacy and Medicine

Sources Revised During this Update:

(Webpage) CITI Program - FAQ (MLI-13) (Current as of September 18, 2023)
Collaborative Institutional Training Initiative (CITI) Program

(Webpage) National Institute of Research in Public Health: BP 1771 Bamako - Mali (MLI-15 - French) (Last Updated August 26, 2023)
Geneva Foundation for Medical Education and Research (GFMER)

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