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

Abstract

Jane H. Mashingia and colleagues reveal the progress made to date for the East African Community Medicines Regulatory Harmonization initiative.

Fig 1. Outcomes for the joint assessment pathway of the East African Community’s Medicines Regulatory Harmonization initiative, from 2015, when the first applications were submitted, through August 2019.

(A) Number of applications submitted, assessed, and recommended for registration. The relative amount of time spent with the regulator versus the manufacturer (while addressing queries from the regulator) is shown for assessments. (B) Number of medicines registered by each of the East African Community’s individual national medicines regulatory authorities, of the 36 recommended to date through the joint assessment pathway. The numbers above each Partner State’s name represent the range of times elapsing from joint assessment recommendation to product registration. These ranges include, where relevant, the time that a manufacturer took to submit an application and payment to the Partner State’s national medicines regulatory authority after receiving a joint assessment recommendation. Some smaller markets, such as Burundi, have received fewer registration applications from manufacturers following the joint assessment process. South Sudan, a new member of the initiative, has not yet started to register products and thus is not shown here.

Fig 2. The joint product assessment pathway of the EAC’s Medicines Regulatory Harmonization initiative.

EAC, East African Community; NMRA, national medicines regulatory authority.

Fig 3. The joint good manufacturing process inspection pathway of the EAC’s Medicines Regulatory Harmonization initiative.

EAC, East African Community; NMRA, national medicines regulatory authority.

Fig 4. Breakdown of donor funding for the EAC MRH initiative, 2012–2017.

EAC MRH Phase 1 lasted from July 2012 through July 2017, and Phase 2, which partially overlapped with Phase 1, lasted from July 2016 through December 2017. Light green represents EAC MRH–specific funding, medium green represents funding for partners, gray represents funding for other MRH initiatives (such as those in the Economic Community of West African States, South African Development Community, and Intergovernmental Authority on Development regions), and dark green represents total funding for the initiative. AMRH, African Medicines Regulatory Harmonization; AUDA-NEPAD, African Union Development Agency–New Partnership for Africa’s Development; EAC MRH, East African Community’s Medicines Regulatory Harmonization; WHO, World Health Organization.