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 Uganda.


In 2015, the inaugural IGAD Member States NMRA’s meeting was held in Addis Ababa, Ethiopia. Uganda successfully participated and signed the Call for Action to implement a regional Medicines Regulatory Harmonization (MRH) programme. A follow up meeting was convened in 2016 and agreed to establish an IGAD MRH Steering Committee, Technical Working Groups (TWG’s) and a Coordination Unit.

After the successful establishment of the East African Countries (EAC) Medicines Regulatory Harmonization (MRH) programme in 2012, Uganda 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 Uganda 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. In 2015, the EAC-MRH programme conducted a Joint Dossier Assessment of 8 medicinal products in Entebbe, Uganda.

The National Drug Authority of Uganda is a designated RCORE specialized in licensing of the manufacture, import, export, distribution and; inspection and surveillance of manufacturers, importers, wholesalers and dispensers of medicines. RCOREs are institutions with specific academic and technical regulatory science expertise and training capabilities capable of producing regulatory workforce in Africa.

Programme Reference
African Medicines Regulatory Harmonisation (AMRH)
Country selection
Uganda
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Key Results
Implementation of harmonised medical product regulatory standards in the East African Community (EAC) came into effect in January 2015. These standards are aimed at facilitating the marketing authorisation of products in the 5 partner States of the EAC region, including Uganda
The continent’s first Model Law on Medical Products Regulation was endorsed by African Leaders in January 2016 to improve access to quality and safe drugs and as well fight the circulation of fake medical products on the continent. Uganda has embraced and domesticated the AU Model Law and is already utilising an adapted version
As a result of the AMRH programmes: harmonised standards have enabled national drug regulatory authorities (NMRAs) in EAC to authorise two Antimalarial Drugs and three Generic Pharmaceuticals; the registration procedure of five medical products was shortened by 30 to 40 per cent, resulting in significant reduction in registration costs; and the inspection of nine manufacturing sites in EAC region as well as Egypt and India with subsequent approval of five facilities
The National Drug Authority of Uganda is a designated Regional Centre of Regulatory Excellence (RCORE) specialized in licensing of the manufacture, import, export, distribution and inspection and surveillance of manufacturers, importers, wholesalers and dispensers of medicines. The institutions mandate includes training of regulatory authorities in the area of specialisation in Africa
Within the realm of boosting implementation of the African industrialisation agenda, various technologies and associated frameworks have been developed to control vectors that transmit infectious disease such as malaria, Zika virus disease and chikungunya. Confined field trials for the vectors have been undertaken in three countries including Uganda
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