Coming together to improve access to medicines: The genesis of the East African Community's Medicines Regulatory Harmonization initiative

Abstract

Hiiti Sillo and colleagues reveal how the East African Community's Medicines Regulatory Harmonization initiative improves access to important medicines in Africa.

Fig 1. Timeline of major events leading to the creation of the EAC’s MRH initiative, a pilot project for the broader AMRH initiative.

AMRH, African Medicines Regulatory Harmonization; EAC, East African Community; MRH, Medicines Regulatory Harmonization.

Fig 2. Time to approve marketing authorization applications in the EAC prior to the EAC MRH initiative.

When the EAC’s MRH initiative began, there was substantial inter- and intra-agency variation in the length of time that NMRAs took to approve marketing authorization applications submitted by global pharmaceutical companies. (A) Median, minimum, and maximum times from the submission of a registration application until its approval by the NMRAs of Kenya, Tanzania, and Uganda. For comparison, times for the US FDA and WHO are shown as well. Data were provided by 10 global pharmaceutical companies to the Boston Consulting Group with the understanding that company and drug names would remain confidential and spanned medicines and vaccine submissions from 1985 to 2012. (B) Even for the same medicine, the time from submission to approval could vary dramatically between NMRAs. Here the time from submission to approval of a single antiretroviral medicine initially submitted to the FDA during the 1985 to 2012 time period is shown for the NMRAs of Kenya, Tanzania, and Uganda, as well as the FDA and EMA for comparison. Source information for Figure from: Ahonkhai et al 2016 [5]. EAC, East African Community; EMA, European Medicines Agency; FDA, Food and Drug Administration; MRH, Medicines Regulatory Harmonization; NMRA, national medicines regulatory authority; WHO, World Health Organization.

Fig 3. Governance structure of the EAC’s MRH initiative.

AUDA-NEPAD, African Union Development Agency–New Partnership for Africa’s Development; EAC, East African Community; MRH, Medicines Regulatory Harmonization; NMRA, national medicines regulatory authority; Swissmedic, Swiss Agency for Therapeutic Products; WHO, World Health Organization.

Fig 4. Role of partners in the EAC’s MRH initiative.

AUDA-NEPAD, African Union Development Agency–New Partnership for Africa’s Development; BMGF, Bill & Melinda Gates Foundation; DFID, UK Department for International Development; EAC, East African Community; MRH, Medicines Regulatory Harmonization; Swissmedic, Swiss Agency for Therapeutic Products; WHO, World Health Organization.