Improving access to quality medicines in East Africa: An independent perspective on theEast African CommunityMedicines Regulatory Harmonization initiative.

Alexander R Giaquinto,Lawrence Liberti,Alberto Grignolo,Tomas Salmonson,Henrietta Ukwu,Fernand Sauer,John C W Lim

doi:10.1371/journal.pmed.1003092

Abstract

Alexander Giaquinto and co-authors discuss the East African Community's Medicines Regulatory Harmonization initiative.

Highlights

The authors believe the East African Community (EAC) Medicines Regulatory Harmonization (MRH) initiative may be able to further improve access to essential medicines by increasing transparency, inviting and responding to feedback from industry partners, consistently meeting its advertised assessment and registration timelines, streamlining the joint product assessment process, taking advantage of work done by peer institutions, focusing on the activities most likely to have the greatest public health return, and using metrics and benchmarks to identify opportunities for greater efficiency
The Committee for Medicinal Products for Human Use (CHMP) draws on scientific expertise from European Union (EU) member states to determine whether the medicine should be authorized
By implementing changes targeting queue time, Health Canada reduced its backlog by 99% between 2000 and 2006 and halved overall application approval times [22]

Summary

Summary points

The goal of improving access to quality medicines in East Africa has been addressed by the East African Community (EAC) Medicines Regulatory Harmonization (MRH) initiative, which is working to simplify the process of registering medicines and increase the speed at which registration applications are reviewed while ensuring that only highquality medicines are approved. The authors believe the EAC MRH initiative may be able to further improve access to essential medicines by increasing transparency, inviting and responding to feedback from industry partners, consistently meeting its advertised assessment and registration timelines, streamlining the joint product assessment process, taking advantage of work done by peer institutions, focusing on the activities most likely to have the greatest public health return, and using metrics and benchmarks to identify opportunities for greater efficiency. The Working Parties draft scientific guidance documents, help evaluate marketing authorization applications submitted via the centralized procedure, and share their guidance and decisions—including the underlying reasoning—with the public It is essential for a harmonization program to describe all regulatory processes in detail in a form readily accessible to all stakeholders. Public debates in which multiple viewpoints can be

National procedure

Findings

Medicines approval system