Approval of conventional medicines in Cameroon in 2023: Why do some fail?

Abstract

This study focuses on the work of the specialized commission responsible for assessing the conformity of registration files for drugs seeking marketing authorization (MA) in Cameroon during 2023, particularly examining why certain applicants submit noncompliant files for approval. First, the files submitted to the specialized commission in 2023 were listed. The data on the reasons for noncompliance were then compiled, and finally, a statistical analysis was performed. Out of the 768 files assessed by the specialized commission in 2023, only 151 (19.6%) were compliant. Letters of observation (LO) were issued for the remaining 617 participants for the following reasons: Lack of bioequivalence studies (19.6%), incomplete or missing finished product stability data (16.8%), primary and secondary packaging and/or package leaflets in one language (11.3%), missing control section from technical dossiers (11.3%), certificate of analysis missing or not signed (8.4%), absence of information on the quality of the active substance (8.1%), absence of edging (6.4%), expired or uncertified good manufacturing practices (GMP) certificate and/or operating license (5.6%), and absence of a route of administration on the primary and/or secondary packaging (4.8%). The first four reasons alone account for more than 55% of the reasons for noncompliance, highlighting the need for targeted communication to improve the compliance rate. This could serve as a partial solution to the availability of pharmaceutical references and drug shortages in Cameroon. Key words: registration, marketing authorization, observation letter, commission spécialisée des médicaments conventionnels, regulatory assessment.