Alliance Launches African Medicines Regulatory Program

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Several high-level international health organizations joined together in Arusha, Tanzania on March 30 to launch the East African Community (EAC) Medicines Registration Harmonization Program, which will help Africans access essential, high-quality, safe and affordable medicines.  The project marks the start of implementing the project across the continent, and brings together the Partnership for Africa’s Development (NEPAD), the World Health Organization (WHO), the Bill & Melinda Gates Foundation, the World Bank, the UK Department for International Development (DfID), and the Clinton Health Access Initiative (CHAI).

According to UNAIDS, the project aims to strengthen regulatory capacity and systems for medicines in Africa, including antiretroviral drugs, so fewer lives are lost due to unsafe and low quality drugs, or drugs that are largely unavailable or inefficiently delivered.  These challenges stem from a lack of human and financial resources, insufficient infrastructure, weak medicine legislation and a lengthy drug approval cycle.

In addition, the project aims to produce creative, African-sourced solutions responsive to the needs of Africans.  Currently, Africa is reliant on imported medicines, with 80 percent of antiretroviral drugs coming from abroad.  The project will encourage local production of medicines in partnership with other emerging economies, such as Brazil, Russia, India, China, and South Africa, or the BRICS group.  This will also strengthen African control of development investments and reduce dependence on external sources.

The UNAIDS press release quotes UNAIDS Deputy Executive Director, Dr Paul De Lay, who said that creating an African Medicines Regulatory Agency would allow faster roll out of drugs, stronger quality assurance, greater public confidence and the enhancement of African ownership of a sustainable AIDS response.

“Access to safe, affordable and quality medicines for the treatment of common diseases remain out of reach to many people in the East African region as a whole,” said Dr Richard Sezibera, Secretary General of the East African Community in the UNAIDS press release. “The program we are launching here today will put in place a uniform and standardized medicines regulatory framework for both good health outcomes and economic gains.”

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