A critical AU Model Law aimed at harmonizing medical products regulatory systems in Africa was endorsed by African Heads of State and Government at the January 2016 AU Summit in Addis Ababa, Ethiopia. The AU Model Law will contribute towards accelerate the regulation of safe, quality and affordable medical products and technologies in Tanzania.
The Headquarters of the East African Community (EAC) is in Arusha Tanzania. In 2012, the EAC Medicines Regulatory Harmonization (MRH) programme was established and Tanzania participated in the development and subsequent adoption of harmonized technical guidelines by the EAC Council in 2014 and publication of a compendium for EAC member states. Two pilot projects: the World Health Organization Medicines Prequalification Program (WHO-PQP) and the EAC Joint Assessments and Inspections ensured that Tanzania participated in the approval of 5 and 7 products in 2011 and 2013 respectively. Phase two of the EAC-MRH programme has expanded to include drug safety (pharmacovigilance) strengthening; clinical trials oversight; regulation and quality assurance of medical devices including diagnostics; and harmonization of regulation of vaccines.
There are two (2) NMRAs participating on the MRH programme in Tanzania, namely the Tanzania Food and Drugs Authority (TFDA) and the Zanzibar Food and Drugs Board. In 2015, the EAC-MRH programme conducted a Joint Dossier Assessment of 8 medicinal products in Entebbe, Uganda. As a result, Tanzania granted conditional approval of four (4) products.
Tanzania has two designated RCOREs specialized in training in core regulatory functions and medicine evaluation and registration namely: St. Luke’s Foundation, Tanzania – Kilimanjaro School of Pharmacy; and School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS) – Tanzania Food and Drugs Authority (TFDA) respectively. RCOREs are institutions with specific academic and technical regulatory science expertise and training capabilities capable of producing regulatory workforce in Africa.