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

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

doi:10.1371/journal.pmed.1003134

Abstract

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

Highlights

Access to essential medicines is a key pillar of any health system seeking to deliver universal health coverage
Though both the World Bank and East African Community (EAC) Secretariat emphasize that their goal is to disburse funds as quickly as possible once they have received the required documentation, National medicines regulatory authorities (NMRAs) report that complying with 2 sets of requirements is cumbersome and that, in some cases, delayed payments have led to joint activities being postponed or NMRAs having to advance money to conduct program activities. Another example of bureaucratic inefficiency is that, initially, the EAC Secretariat was responsible for hiring the officers stationed at NMRAs who were tasked with conducting key initiative activities. If one of these officers was not meeting their responsibilities at the NMRA, the Head of that NMRA had a difficult time holding him or her accountable, because the officer answered to the EAC Secretariat
The EAC’s Medicines Regulatory Harmonization (MRH) initiative reduced the amount of time it took to register medicines in individual countries by about half. It did so by instituting a suite of regulatory standards and processes aligned across the region, as well as by building the capacity of all its Partner States’ NMRAs to engage in regulatory activities

Summary

Summary points

Access to essential medicines is a key pillar of any health system seeking to deliver universal health coverage. In this article, we explore the progress the East African Community’s Medicines Regulatory Harmonization (EAC MRH) initiative, launched in 2012, has made toward its goal of improving access to essential medicines. From 2012 to 2017, the timeline for national assessments of medicinal product applications decreased from roughly 24 months to 8–14 months, if products were assessed through the new joint assessment process (involving 2 or more national medicines regulatory authorities). Since 2015, the initiative has conducted 10 joint product assessment sessions in which 83 medicinal product applications were considered, resulting in the recommendation of 36 products for registration by EAC Partner States. Technical Requirements for Pharmaceuticals for Human Use; IMS, information management system; ISO, International Organization for Standardization; MRH, Medicines Regulatory Harmonization; NMRA, National medicines regulatory authorities; QMS, quality management system; SOP, standard operating procedure; Swissmedic, Swiss Agency for Therapeutic Products; WHO, World Health Organization. Shifting from relying on donor support to becoming self-sustaining remains a challenge for the EAC MRH initiative

Introduction

Conclusion