The Zanzibar House of Representatives has successfully approved the bill amending the legislation on medical products regulation based on the African Union (AU) Model Law on medical products regulation. Following this development, H.E the President of Zanzibar, Ali Mohamed Shein is expected to append his signature before the statute is officially published in the Government Gazette.
Other AU Member States that have already utilised the AU Model Law to review and develop their national laws include Lesotho, Seychelles, Swaziland, Zimbabwe, and Ivory Coast. The aim is to have at least 25 AU Member States using a version of the AU Model Law on medical products regulation that befits their country context by 2020. The AU Model Law is available in English, French, Portuguese and Arabic.
Zanzibar Food and Drugs Board (ZFDB) Registrar, Dr Burhani Othman Simai thanked the different stakeholders and partners for their endless support and encouragement that has led to this achievement as it will benefit the people of Zanzibar.
The AU Model Law on medical products regulation addresses the challenges of weak or non-existent medical products regulatory systems and assists African countries in addressing the gaps and inconsistencies in their legislations. The aim of the AU Model Law is to accelerate access to innovative, lifesaving health technologies to the African population by facilitating harmonization of medical products regulatory systems on the continent.
The AU Model Law was officially endorsed by the Heads of State and Government at the AU Summit in Addis Ababa, Ethiopia in January 2016. Following the endorsement, Regional Roadmaps for implementation of the AU Model Law have been developed and African countries can enact a version of the AU Model Law to strengthen their national regulatory capacity.
The African Medicines Regulatory Harmonisation (AMRH) Initiative played a critical role in getting the AU Model Law adopted by the AU Heads of State and Government. The AMRH Initiative is a partnership comprised of the NEPAD Agency, African Union Commission, Pan African Parliament, the World Health Organisation, World Bank, Bill and Melinda Gates Foundation, and UK Department for International Development. The goal of AMRH is to strengthen the capacity for regulation of medical products in Africa and promote harmonisation of medicines regulatory systems. The development process of the AU Model Law was also supported by the United Nations Development Programme.