Launching of the West Africa Medicines Registration Harmonization Project

Submitted by admin on Mon, 12/28/2015 - 13:23
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After the Southern and East African regions, West Africa will launch its Medicines Registration Harmonisation Project on February 2 to 5 in Accra Ghana, to ensure rapid access to safe and effective medicines of good quality for the treatment of priority diseases and to fast-track the registration of such products.

Led by the NEPAD Agency through the Technical Working Group  on Medicines Policy and Regulatory Reforms and in collaboration with the African Union Commission (AUC), Regional Economic Communities (RECs),  the Pan African Parliament (PAP) as well as partners such as the World Health Organisation (WHO), United Nations Development Programme (UNDP), World Bank and Bill and Melinda Gates Foundation, the gathering will also be a platform to discuss the draft African Union model law and other key documents.

According to a study conducted by the NEPAD Agency in all the RECs and National Medicines Regulatory Authorities (NMRAs), it is noted that although most of the countries have policies and legislation that give governments the mandate to regulate medical products; these legislations however vary in comprehensiveness from country to country.

The study results also showed that most of the countries that have policies in place have not developed their implementation plans. This creates a gap in the execution of the existing policies and in turn affects local medicines regulation. Furthermore, due to the territorial nature of most of the existing legislation, countries are neither obliged to use decisions made by another NMRA nor decisions made at the regional level; this affects their participation in regional medicines regulatory harmonization efforts.

The Accra meeting will also be an opportunity to discuss the African Union’s Response to the Ebola Epidemic in West Africa (ASEOWA). To that end, the NEPAD Agency is working with the West Africa Health Organization (WAHO) of the Economic Community of West African States (ECOWAS) to establish a regional experts working group on trials for Ebola vaccine and other promising treatment options in order to accelerate their evaluation.

The NEPAD Agency is placing emphasis on mobilising African countries to put in place conducive and enabling environments for conducting clinical trials to test the candidate vaccines and other therapies against Ebola.

It is expected that at the end of the meeting, Common Action Plans for the entire region will be approved for implementation and confidence will be built within ECOWAS MRH by development partners to attract funding and technical support.