Snapshot

The Joint assessments of applications for marketing authorization in the CEMAC zone pathway has been developed by the of Economic and Monetary Community of Central Africa (CEMAC).

This pathway can be used where new chemical or biological entities (originator medicines), including enhanced traditional medicines; complex generic products; vaccines; other biologics such as biotherapeutics and similar biotherapeutics (including gene therapies and advanced gene therapies). .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Cameroon Central African Republic Chad Congo Equatorial Guinea Gabon

The joint evaluation process of marketing authorization (MA) applications in the CEMAC zone takes place in 3 phases: Phase 1: Call for Expressions of Interest. 1. The Executive Secretary of OCEAC will launch a call for expressions of interest for the marketing of medicines belonging to the CEMAC priority categories identified jointly by OCEAC and the member states. 2. The applicant will compile its product dossier in CTD format and submit the application in a sealed envelope labelled "CEMAC Joint Evaluation Application" to the one of the six CEMAC NRAs within 90 days of the publication of the call. The envelope must also contain the electronic version of the product dossier on a USB stick/drive. Samples of the reference products and substances must be submitted at the same time as the product dossier. Phase 2: Administrative evaluation of product dossier. The Technical Secretariat will carry out an administrative evaluation of the product dossier with a view to its admissibility and issue the applicant, within 15 days of the closing of the call for expressions of interest, a notification of acceptability or non-acceptability. For each accepted marketing authorization application, the applicant must pay the joint evaluation fee within 15 days of notification to the OCEAC account. Phase 3: Technical evaluation of the product dossier. The technical and scientific evaluation is carried out by the members of the Committee of Experts. The number and profile of experts will be determined by the Technical Secretariat depending on the product dossiers that need to be evaluated. The purpose of the assessment is to ensure that the product meets international quality requirements and is manufactured in accordance with Good Manufacturing Practices (GMP). The evaluation will include, but is not limited to: general understanding of the manufacturer's production and quality control activities; evaluation of data and information on the safety, efficacy and quality of the product provided by the manufacturer, including formulation, manufacturing and product data and test results; assessment of the manufacturing site's GMP compliance and consistency in production and quality control of raw materials, with a particular focus on active pharmaceutical ingredients and the finished product; the evaluation of quality control units to verify their compliance with good laboratory practice, where applicable; and testing of submitted product samples. This period of evaluation of the files by the experts will not exceed 30 days. Following the evaluation by the experts, the Technical Secretariat will organize a first meeting of the Committee of Experts. The person responsible for evaluation and registration in each CEMAC NRA will be invited to this meeting. The meeting will be organized in accordance with the rules in force in the CEMAC. The experts will appoint a chair and a rapporteur for the meeting. They will discuss the marketing authorization applications submitted for review and the issues raised during the review. A preliminary report will be produced and sent to the Technical Secretariat, together with a List of Questions/queries (LoQ) and other comments for the attention of the applicant. The applicant will have 60 days to respond to the LoQ. After this period, the Technical Secretariat must note the absence of a response and declare the file as rejected. The responses to the LoQ will be assessed by the experts who will then generate their assessment report. This will be discussed at a second meeting of the Committee of Experts, organized by the Technical Secretariat and in which the heads of the NRAs of the 6 countries will take part. This meeting will adopt the experts' report and reach a conclusion on whether the medical product has all the necessary qualities to be placed on the CEMAC market. The Technical Secretariat will send the applicant the assessment report of the joint evaluation of its MA application file. The entire joint assessment process, from the close of the MA application intake period to the transmission of reports to applicants, will have to take place within 135 days, not including the 60 days given to applicants to provide any clarifications. NATIONAL LEVEL REGISTRATION PROCEDURES: The issuance of the marketing authorization is the responsibility of the NRA of the country concerned. After receipt of the joint evaluation report, the applicant will have to follow the registration procedure in force within the CEMAC country(ies) requested, with a view to the registration of its drug(s). However, this procedure will be simpler and faster, as the product has already undergone a technical evaluation. The Technical Secretariat will monitor MA applications in CEMAC member countries and ensure that marketing authorizations are issued within 45 days.