A new approach to an old problem: Overview of the East African Community's Medicines Regulatory Harmonization initiative

• Published in: PLoS medicine Vol. 17; no. 8; p. e1003099
• Main Authors: Ndomondo-Sigonda, Margareth, Mahlangu, Gugu, Agama-Anyetei, Margaret, Cooke, Emer
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 01.08.2020; Public Library of Science (PLoS)
• Subjects: Africa, Eastern - epidemiology; Anti-Bacterial Agents - standards; Antimalarials - standards; Antiviral Agents - standards; Collection Review; Community Medicine - legislation & jurisprudence; Community Medicine - standards; Community Medicine - trends; Drug and Narcotic Control - legislation & jurisprudence; Drug and Narcotic Control - trends; Humans; Information sharing; Initiatives; Medical equipment; Medicine; Medicine and Health Sciences; People and Places; Quality of Health Care - legislation & jurisprudence; Quality of Health Care - standards; Quality of Health Care - trends; Regulation; Research and Analysis Methods; Social Sciences; Africa, Eastern; Uganda; South Sudan; Kenya; Rwanda; Africa; Tanzania
• ISSN: 1549-1676; 1549-1277; 1549-1676
• DOI: 10.1371/journal.pmed.1003099

Summary points * Substandard and/or falsified medical products may result in treatment failure and/or death. * The capacity to regulate medical products is key for ensuring the quality, safety, and efficacy of medical products circulating in a market. * The experience of the East African Community, during its piloting of the Medicines Regulatory Harmonization initiative, serves as a lesson for scaling up the African Medicines Regulatory Harmonization Program across the continent. * Currently, the East African Community’s Medicines Regulatory Harmonization initiative is poised to transition from a donor-funded pilot project into a self-sustaining, permanent feature of the African regulatory landscape. * Government, partner, and public support is needed for strong systems to regulate medicines in the East African Community and elsewhere in the world. With support from partners including the AU Development Agency–New Partnership for Africa’s Development, World Bank, World Health Organization, Swiss Agency for Therapeutic Products (Swissmedic), United Kingdom Department for International Development, and Bill & Melinda Gates Foundation, the initiative provided the needed technical, financial, and political advocacy support. The importance of regulatory harmonization and cooperation in ensuring access to quality versions of essential medicines is well recognized [13]. [...]in this Special Collection of 5 articles, we describe the EAC MRH initiative from its beginning through its plans for the future. Sharing information about the EAC MRH initiative is also important because it represents the first step on a path leading toward continent-wide, coordinated regulation of medicines. Since the EAC MRH initiative started, a number of other regional economic communities have launched their own regional harmonization initiatives.