EAC to harmonize registration of drugs

 EAST African Community (EAC) member states are set to have harmonized registration of medicines in a bid to improve public health in the region.

The New Partnership for Africa Development (NEPAD) Planning and Coordinating Agency will at the end of this month launch the EAC Medicines Registration Harmonization (MRH) project in Arusha.The NEPAD Chief Executive Officer, Dr Ibrahim Assane Mayaki said the regulation of medicines and harmonization of technical standards and legislative frameworks have emerged as important components of the regional economic integration efforts.

Mr Mayaki said the launch of the EAC MRH Project marks the beginning of the implementation phase of the AMRH Programme across Africa. "Moreover, it is also a milestone reached towards improving access to essential medicines for priority diseases in Africa," he explained.

Ministers, high-level representatives from the African Union Commission (AUC), the NEPAD Agency, EAC Officials, representatives of EAC National Medicines Regulatory Authorities (NMRAs), regional pharmaceutical associations, international organizations and donors will grace the event. 

Prior to the launch, a stakeholders' technical consultation will be held on March 29 and the inaugural meeting of the AMRH Programme Advisory Committee will take place on 30 March, testifying to the accomplishment of another key milestone of the AMRH Programme.

According to the statement after a series of rigorous consultations with National Medicines Regulatory Authorities Regional Economic Communities (RECs), and industry, AMRH partners have successfully finalized and secured funding for the EAC MRH Project.In addition, proposals for SADC and ECOWAS regions are at an advanced stage for donor consideration, the statement added.

The AMRH Programme assists African countries and regions to respond to the challenges arising in harmonizing medicines regulations as an important, but neglected area of access to medicines. It seeks to support African Regional Economic Communities (RECs) and countries in harmonizing medicines regulations and is mobilizing interested donors and other stakeholders that can contribute to the programme objectives with the requisite support.

The AMRH Programme was initiated at a NEPAD and Pan-African Parliament (PAP) consultation meeting in February 2009, hosted in collaboration with a consortium of partners including the World Health Organization (WHO), Bill & Melinda Gates Foundation, the UK Department for International Development (DFID) and Clinton Health Access Initiative (CHAI).A press statement from the agency noted that the exercise is being conducted on behalf of the African Medicines Regulatory Harmonization Programme partners, will promote harmonization of medicines registration in the region.

The African Medicines Regulatory Harmonization Programme partners are the World Health Organization (WHO), the Bill & Melinda Gates Foundation, the World Bank, UK Department for International Development (DfID), and Clinton Health Access Initiative.According to the statement, harmonization of medicines registration in the region is the key contributor to improved public health and leads to rapid access to good quality, safe and effective medicines for priority diseases.

"Essential medicines save lives and improve health when they are available, affordable, of assured quality and used rationally. However, lack of access to essential medicines remains one of the most serious global public health problems," read the statement in part.

Africa's regions have similar health and technological challenges and relatively low levels of investment in health research, drug discovery and pharmaceutical development, compared to other continents, it further noted.NEPAD noted that countries in Africa are struggling to produce, procure and make safe and essential medicines available to their populations.

"This is because of limited budgets, lack of adequate infrastructure and human resources and a range of regulatory barriers including weak and/or absent medicines legislation and legal frameworks," the statement added.