W/A to launch Medicines Registration Harmonisation Project

After the Southern and Eastern Africa regions, the West Africa Region, would launch the Steering Committee and Technical Working Group of the ECOWAS Medicines Regulatory Harmonisation Project in Accra.

The meeting would be held from February 2- February 5.

The Project is meant to ensure rapid access to safe and effective medicines of good quality to treat priority diseases and to fast track registration of such products.

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

According to a study on situation analysis conducted by the NEPAD Agency in the RECs and National Medicines Regulatory Authorities (NMRAs), it is noted that although most of the countries have policies and legislation that gives the government mandate to regulate medical products; these legislations 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 and this creates a gap in the execution of the existing policies and in turn affects local medicines regulation.

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 and this affects their participation in regional medicines regulatory harmonisation efforts.

The Accra meeting would also be an opportunity to discuss the African Union’s Response to the Ebola Epidemic in West Africa.

To this end, the NEPAD Agency is working with the West Africa Health Organisation of the ECOWAS to establish regional experts working group on trials for Ebola vaccine and other promising treatment options in order to accelerate their evaluation.

Moreover, 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 would be approved for implementation and confidence would be built within ECOWAS Medicines Regulatory Authorities by development partners to attract funding and technical support.