Snapshot

The West African Health Organization (WAHO) Regional Joint Assessment Procedure for Medicine Registration and Marketing Authorization of Medicinal Products pathway has been developed by the WAHO of West African Health Organization (WAHO).

This pathway can be used where New chemical entities, biologicals, biosimilars, generics..

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: Benin Burkina Faso Cape Verde Cote D'Ivoire Gambia Ghana Guinea Guinea-Bissau Liberia Mali Niger Nigeria Senegal Sierra Leone Togo

Currently, the West Africa has no Regional Medicines Regulatory Agency, which has legal mandate for marketing authorization of medicinal products. In view of this, and within the framework of the West African Medicines Regulatory Harmonization (WA-MRH) Initiative, selected medicines in the regional basket will be authorized through the national authorization procedure, after the joint assessment procedure. In the current operating model of the WA-MRH initiative, an NMRA serves as a lead coordinator for a 2-year period and receives, validates and arranges for the assessment of the dossiers and additionally communicates with applicants and the WAMRH secretariat, which is based in the WAHO. There are 11 steps in the WA-MRH joint assessment procedure which include: expressions of interest; pre-submission meeting; submission and dossier validation; technical evaluation (Phase I); joint evaluation by the expert working group (EWG) and technical partners (Phase I); joint good manufacturing practice inspection and quality control; technical evaluation (Phase II); joint evaluation by expert working group and technical partners (Phase II); technical evaluation (Phase III); final joint evaluation by EWG and technical partners; and validation by WA-MRH Steering Committee. In summary, it takes 120 and 226 calendar days for a high standard-completed dossier and a dossier with a one-time list of questions to go through these 11 steps, respectively. The WA-MRH joint assessment process flowchart is on page 3 of 11 of Owusu-Asante et al.'s publication (See references).