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 Kenya.
In 2015, the inaugural IGAD Member States NMRA’s meeting was held in Addis Ababa, Ethiopia. Kenya 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, Kenya 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 Kenya participated in the approval of 5 and 7 products in 2011 and 2013 respectively. The EAC-MRH programme conducted a Joint Dossier Assessment of 8 medicinal products in Entebbe, Uganda in 2015; Four (4) of which were already registered by the Pharmacy and Poisons Board of Kenya. 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.
Kenya has a designated RCORE specializing in Pharmacovigilance called Pharmacy and Poisons Board (PPB) of Kenya. RCOREs are institutions with specific academic and technical regulatory science expertise and training capabilities capable of producing regulatory workforce in Africa.
Key Results
Improved and harmonised policy and institutional frameworks for implementation of harmonised medical product regulatory standards in the EAC came into effect in January 2015
A critical AU Model Law aimed at harmonising medical products regulatory systems in Africa was endorsed by African Heads of State and Government including Kenya at the January 2016 AU Summit in Addis Ababa, Ethiopia. The AU Model Law will contribute towards accelerating the regulation of safe, quality and affordable medical products and technologies in Kenya
Kenya participated in the 2015 inaugural IGAD Member States National Medicines Regulatory Authority (NMRA) meeting and signed the Call for Action to implement a regional Medicines Regulatory Harmonisation (MRH) programme. The Country has been actively involved in the IGAD MRH Steering Committee, Technical Working Groups (TWG’s) and a Coordination Unit
Kenya has also adopted the NMRA standards aimed at facilitating the marketing authorisation of products in the five partner States of the region. The standards have enabled national drug regulatory authorities (NMRAs) in the EAC region, including Kenya, to authorise 643 products individual and 4 products through joint assessments with Uganda and Tanzania
Furthermore, nine manufacturing sites in the East African Community as well as Egypt and India have been inspected resulting in approval of 5 facilities. These efforts are geared toward facilitating faster approval of medicines that meet internationally acceptable standards of quality, safety and efficacy
In 2012, Kenya participated in the development and subsequent adoption of harmonised 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 have increased Kenya’s capacity to ensure drug safety (pharmacovigilance), strengthened clinical trials oversight, regulation and quality assurance of medical devices including diagnostic, and harmonization of regulation of vaccines
