West Africa Medicines Regulatory Harmonization Project (WA-MRH)

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Objective

To Improve the availability of quality, safe and effective medicines and vaccines in the ECOWAS region. IT supports medicines and vaccines registration harmonization among fifteen (15) NMRAs in the ECOWAS region; and improve efficiency and transparency in the registration of medicines and vaccines used for preventing and treating diseases. The WA-MRH Regional Joint Assessment Procedure is an efficient way to introduce innovative medical products for treatment of conditions of public health importance, reduce duplication of efforts and is less costly to both Pharmaceutical Manufacturers and Governments. The programme employs scientific based assessment, inspections and principles of work and information sharing, convergence and reliance on regulatory decisions.

Why participate?

The results of research carried out by the WHO Prequalification Team: medicines (PQTm) indicated that manufacturers can benefit from participating in regional prequalification like WA-MRH in a number of ways. They may include:

increased sales or market access

• eligibility for international, donor-sponsored tenders for medicines
• improved capacity to manufacture products for entry into stringently-regulated markets
• increased potential to compete successfully for contract manufacture for local markets
• faster registration

improved image or brand

• status associated with producing quality-assured products
• enhanced image both externally and internally

reduced manufacturing costs

• due to improved capacity utilization
• lower variable/commercial operating costs

increased capacity/skills

• development of human resources for ensuring and managing quality manufacture
• capacity to ensure quality manufacture across range of products
• new or increased capacity to meet stringent regulatory requirements.

Which manufacturers can participate?

Any manufacturer of an active pharmaceutical ingredient (API) or finished pharmaceutical product (FPP) within the ECOWAS region may apply for prequalification of its product(s), provided that the API or FPP is eligible for prequalification. As of date, local manufacturers from the 15 ECOWAS countries have an FPP or FPPs listed on the WAHO PQ FPPs lists

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How to Participate

• Applicant responds to Expression of Interest issued by the East African Community Secretariat; or,
• Marketing Authorizations and GMP Applications filed in more than one NMRA (common applications) are eligible upon consenting to the joint procedure by the applicant