Situation Analysis Study on Medicines Registration Harmonisation in Africa – Final Report for the Economic Community of West African States (ECOWAS)


This Situation Analysis Report on Medicines Registration Harmonisation for the Economic Community of West African States (ECOWAS) has been prepared following rigorous scientific methods and participatory methods. Assessment instruments (AI) consisting of three separate structured questionnaires were administered at REC, Regional/National Association of Pharmaceutical manufacturers and NMRA levels to gather information from a representative cross section of stakeholders, and analyzed to give a reflection of the situation of medicine registration harmonisation. In addition focus group discussions (FGD) and key informant interviews were conducted in order to collect both qualitative and quantitative data. The purpose of the Situation Analysis serves to establish the status of medicines regulation capacity, harmonisation efforts and challenges in ECOWAS and Member States with a view to enhancing a better understanding of the situation in the region, learn from past experiences and develop appropriate interventions to facilitate AMRH. The report has been prepared by the consultant with invaluable support received from the West African Health Organization (WAHO), Heads of National Medicines Regulatory Authorities and Pharmaceutical Manufacturers and their Associations. This great support catalysed the collection of data and validation of this report. The report serves among other things as a baseline on the status of medicines regulatory harmonisation in the region, and focuses efforts towards responding to identified gaps, while capitalizing on existing strengths.

This Situation Analysis Report and the important data it provides is timely for the ECOWAS sub-region, in order to expedite efforts to increase the availability of quality and affordable medicines and to counter the huge burden of Malaria, HIV/AIDS, Tuberculosis, neglected tropical diseases and other newly emerging diseases that are generally faced by the countries of this region.