Journal Article

Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned

Azatyan, Samvel, Seiter, Andreas, Maboko, Shani, Harris, Rachelle, Arik, Mawien, Sigonda, Margareth, Angole, Apollo, Yano, Felistas, Simai, Burhani, Fimbo, Adam, Baak, Peter, Hamad, Hidaya, Ahonkhai, Vincent, Karangwa, Charles, Muhairwe, Apollo, Bamenyekanye, Emmanuel, Hartman, Dan, Mwesigye, John Patrick, Lumpkin, Murray, Bizoza, Aimable, Chamdimba, Chimwemwe, Gisagara, Alex, Kabatende, Joseph, Sematiko, Gordon, Sillo, Hiiti, Matle, David, Mashingia, Jane H., Tanui, Paul, Ambali, Aggrey, Ward, Mike, Siyoi, Fred, Sonoiya, Stanley, Mukanga, David, Doerr, Petra, Kijo, Agnes Sitta, Schulze, Alexander, Nyabenda, Bonaventure, Aineplan, Noel

2020

Overview

According to the World Health Organization (WHO) [1], NMRAs contribute to promoting and protecting public health and safety by ensuring that. * medicines are of the required quality, safety, and efficacy; * health professionals and patients have the necessary information to enable them to use medicines rationally; * medicines are appropriately manufactured, stored, distributed, and dispensed; * illegal manufacturing and trade are detected and adequately sanctioned; * promotion and advertising are fair, balanced, and aimed at rational drug use; and * access to medicines is not hindered by unjustified regulatory work. Afterward, the medicines were registered by Kenya and Uganda (although the medicines were eligible for registration in all EAC countries, the manufacturer decided to register them in only 3). Because of this new regional approach to product assessment, these medicines were available in EAC countries sooner than they would have been otherwise. [...]the EAC MRH initiative was expected to identify a funding mechanism that would allow it to sustain and broaden its regulatory activities after the catalytic donor support available for the first 5 years expired. The initiative’s Medicines Evaluation & Registration Working Group, led by Tanzania’s NMRA, created this CTD as part of the program’s larger mandate of harmonizing technical requirements, standards, and standard operating procedures (SOPs) for medicines assessment and registration across the region [8]. Because the EAC’s CTD is based on the formats used by ICH and the WHO’s Prequalification Programme, EAC Partner States can easily leverage dossiers previously submitted to other regulatory authorities, such as the WHO, US Food and Drug Administration, or European Medicines Agency.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Africa, Eastern - epidemiology / Collection Review / Community Medicine - legislation & jurisprudence / Community Medicine - trends / Drug and Narcotic Control - legislation & jurisprudence / Drug and Narcotic Control - trends / Drug Approval - legislation & jurisprudence / Health Services Accessibility - legislation & jurisprudence / Health Services Accessibility - trends / Humans / Manufacturers / Medical personnel / Medicine and Health Sciences / Multinational corporations / People and Places / Public health / Registration / Regulation / Regulatory agencies / Time Factors