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 Burundi.
After the successful establishment of the East African Countries (EAC) Medicines Regulatory Harmonization (MRH) programme in 2012, Burundi 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 Burundi 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. Currently, the Burundi Department of Pharmacy and Medical Laboratories (DPML) is awaiting to receive dossiers.
Key Results
After the successful establishment of the East African Countries (EAC) Medicines Regulatory Harmonization (MRH) programme in 2012, Burundi 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 ensured that Burundi participated in the approval of five (5) and seven (7) products in 2011 and 2013 respectively. Phase two of the EAC-MRH programme 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. Currently, the Burundi Department of Pharmacy and Medical Laboratories (DPML) is awaiting to receive dossiers
Implementation of harmonised medical product regulatory standards in the EAC came into effect in January 2015. These standards are purposed at facilitating the marketing authorisation of products in the five partner States of the region – including Burundi
The standards have enabled national drug regulatory authorities (NMRAs) in the EAC region, to authorise 5 medical products. In addition, harmonisation of guidelines and standards for inspection of pharmaceutical manufacturing sites has resulted in inspection of 9 manufacturing sites in the East African Community region as well as Egypt and India with subsequent approval of 5 facilities. All these effort are geared toward facilitating faster approval of medicines that meet internationally acceptable standards of quality, safety and efficacy
A critical AU Model Law aimed at harmonising medical products regulatory systems in Africa was endorsed by African Heads of State and Government, including Burundi, 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 Burundi
