ECOWAS Essential Medicines & Vaccines

Author: WAHO

Category: Medical Products Dossier Evaluation and Registration

Language: English

Date Updated:

Description West Africa Medicines Regulatory Harmonization (WA- MRH) Regional Joint Assessment Procedure for Medicine Registration and Marketing Authorization of Medicinal Products

Abstract Access to medicines is a key element of well-functioning health system. The availability and accessibility of medical products that are of acceptable quality, safety, and efficacy, are very important to make a responsive health system that can overcome the challenges facing public health. In West Africa, despite the concerted efforts of the Government and Development Partners, the availability of quality medical products remains a major concern in most countries. Access to quality pharmaceutical products is inadequate because of various deficiencies related to poor governance of the pharmaceutical sector and weak regulatory capacity of the National Medicines Regulatory Authorities (NMRAs). According to a NEPAD and WAHO Assessment in 2010-2011, the medicines regulatory systems In the Sub-Saharan African countries are affected by fragmented legal framework, limited autonomy, lack of sustainable funding, poor infrastructure and institutional capacity, lack of cooperation amongst the Authorities that are responsible for applying the Law, inadequate human resources, dependence on imported products, inadequate capacity of the Quality Control Laboratories to meet the requirements of the WHO Prequalification and lack of information sharing amongst the Agencies. All of these have resulted in cumbersome and non-transparent processes for medicine registration and insufficient regulatory capacity to approve medicines for sale in a timely manner. This has imposed a huge demand on manufacturers when registering new medicines. In order to overcome the challenges posed by the proliferation of illicit, substandard and falsified medicines circulating in the region, and to improve the accessibility of quality, safe and efficacious medicines, in 2014 the leadership of the West African Health Organization (WAHO) and West Africa Economic and Monetary Union (WAEMU) or “Union Economique et Monétaire OuestAfricaine (UEMOA)”, agreed to strengthen their collaboration and stronger coordination in medicines regulatory harmonization (MRH) for the West Africa region. They further agreed that the Medicines Regulatory Harmonization (MRH) management for the entire ECOWAS region be under the control of WAHO. These initiatives include strengthening the local pharmaceutical industry, anti-counterfeiting strategies, support to capacity building initiatives of NMRAs and encouraging a dialogue for harmonization of medicines registration systems.

WA-MRH Regional Joint Medicines Assessment procedure