Meeting of Experts Working Groups to Finalize Technical Documents for Medicines Regulatory Harmonization (MRH) in ECOWAS Region

Meeting of Experts Working Groups to Finalize Technical Documents for Medicines Regulatory Harmonization (MRH) in ECOWAS Region

Bobo-Dioulasso - The West African Health Organization (WAHO) under the leadership of ECOWAS, and Union Economique et Monetaire Ouest Africaine (UEMOA) came together in 2014 and agreed on a roadmap for implementation of a Medicine Regulatory Harmonization (MRH) initiative in the West Africa region.

Over the period of five years, the agreement has yielded several fruits among which are the formation of a Regional Steering Committee comprising the fifteen (15) Member States’ National Medicines Regulatory Authorities (NMRAs), WAHO, UEMOA and African Medicines Regulatory Harmonization (AMRH) Partners; installation of the seven (7) Expert Working Groups (EWGs) which are: (i) Medical Product Dossiers Evaluation and Registration (MPDER), (ii) Good Manufacturing Practice and Inspections (GMP/Inspections), (iii) Clinical Trials and Pharmacovigilance (CT/PV), (iv) Quality Control Laboratory (QCL), (v) Quality Management System (QMS), (vi) Information Management System (IMS) and (vii) Policy, Regulation and Legislation (PLR), to provide technical support and draft harmonized technical requirements and procedures for the various regulatory themes.

Other fruits of the WAHO-UEMOA relationship include the finalization of a harmonized Common Technical Document (CTD) which has been adopted by the 19th Ordinary Session of the Assembly of Health Ministers (AHMs) in Banjul, The Gambia, in June 8, 2018 for use of Member States; training of the Regulators and Local Pharmaceutical Industry on the applicability of the harmonized CTD and development of over one hundred and thirty-three technical documents to support the MRH activities.

To further ensure the achievement of one of the high points of the Medicines Regulatory Harmonization initiative, which is the joint assessment of medical product dossiers by the fifteen (15) National Medicines Regulatory Authorities in ECOWAS, the EWGs on Medical Products Dossier Evaluation and Registration and Policy, Regulation and Legislation met in Bobo-Dioulasso, Burkina Faso, from May 13-17, 2019 to finalize the Procedure that will be followed for Regional Joint-Registration, develop the Expression of Interest (EOI), conclude the assessment of two products – Chlorhexidine gel and Fluconazole Infusion, and finalize the Regional Pharmaceutical Policy and Regulations that would empower the processes.

We look forward to the full implementation of the CTD to improve access to essential medicines in the West African region.



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