Marketing Authorisation for Medicines in Mali: Issues and Prospects

Introduction: Medicines are special products, and their marketing requires an evaluation of the benefit-risk ratio, which leads to the granting of a marketing authorisation (MA). The objective was to study the conditions for issuing marketing authorisations in Mali. Materials and methods: This was a retro prospective cross-sectional descriptive study conducted from 01 January to 31 December 2019 at the Directorate of Pharmacy and Medicines. It included registration applications examined in 2019 and marketing authorisation applications for medicines for human use. Data entry and analysis was done with SPSS 21.0. Results: Of the 848 dossiers reviewed, 594 were favourable and 254 were unfavourable to the national marketing authorisation commission. Among the 254 refusals, 162 were due to price non-competitiveness, 91 to package insert defects, and only one to an inconclusive clinical study. Conclusion: This study allowed us to note a high number of references for the molecules amoxicillin, amoxicillin-clavulanic acid, artemether-lumefantrine, omeprazole, paracetamol, ceftriaxone.