Snapshot

The Licensing of Pharmaceuticals for Human Use in WAEMU Member States pathway has been developed by the of West African Economic and Monetary Union (WAEMU).

This pathway can be used where This pathway is for pharmaceutical products for human use intended to be placed on the market of a Member State of the Union, in the form of a proprietary medicinal product, a generic medicinal product or a multi-source medicinal product..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

DESCRIPTION OF THE MAIN STEPS 1. Receipt of the application for approval. During the approval process, the authority verifies the completeness of the application for approval. This verification will be carried out on the basis of the following criteria: - CTD compliant file - Composition of the dossier in accordance with the type of product and the nature of the application - Sample and certificate of analysis of the deposited batch - Receipt of payment To this end, incomplete applications are not received. For any application for approval, a certificate of submission of the application is issued by the Senegalese national medicines regulatory authority upon receipt of the application. 2. Analysis and administrative evaluation of the application file. The aim is to assess the admissibility of the application on the basis of the defined admissibility criteria. Inadmissible applications will be notified to the applicant with a period of time (three months) to complete them. The complete files are sent to the committee of experts for the technical evaluation and then placed on the agenda of the national approval commission for a final opinion. 3. Analysis and technical evaluation of the file. This is the evaluation of the quality, safety and efficacy of the product submitted for registration. At this stage, the files will be evaluated by the members of the committee of experts on the basis of a technical evaluation guide. 4. National Medicines Commission. The administrative and technical reports are submitted to the National Medicines Commission, which issues an opinion. These opinions are of several kinds: - Accepted - Accepted with reservation - Adjourned (additional information is notified to the applicant) - Rejected with the possibility of appeal only once The committee will essentially decide on the criteria that have been set out in the regulation. NB: The National Medicines Commission validates the Marketing Authorization application files by reference to the following assessment elements: the report and technical opinion of the committee of experts, therapeutic interest and efficacy, the safety of the product under normal conditions of use, the Wholesale Price Excluding Tax (PGHT), the cost of daily and total treatments, and the number of similar multi-source end products on the market. 5. Processing time for a marketing authorization application. The processing time for a new marketing authorization is at least 120 days. However, this period may not exceed 360 days. If information is requested following the administrative evaluation or by the evaluation committees of the file, this processing time is stopped, and a window will be observed during this period. The 120-day count will resume when the information has been submitted to the regulator by the applicant. In the event of an application being refused, the Pharmaceutical Regulatory Authority shall notify the applicant of the refusal decision within a maximum period of 30 working days from the date of the session of the National Medicines Commission.