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

Abstract

• Independent, science-based regulation of medical products is a critical part of ensuring quality healthcare. When conducted in a transparent, science-based, efficient, accountable, and predictable manner, it can help ensure access to quality products that patients need.

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

“…As described in an accompanying article in this collection, Coming together to improve access to medicines: The genesis of the East African Community's Medicines Regulatory Harmonization initiative [6], the overarching vision of the EAC's MRH initiative was to increase the number of quality medicines registered in the region by (1) simplifying the application process for manufacturers and (2) increasing the efficiency with which applications were assessed by Partner States-without sacrificing product efficacy, safety, or quality. In pursuit of this vision, the initiative originally decided to focus on Although its initial focus was on registering generic medicines, the plan was for the initiative to later expand to other classes of medical products, such as biosimilars, vaccines, and medical devices, as well as to other regulatory functions, such as clinical trials oversight and pharmacovigilance.…”

A new approach to an old problem: Overview of the East African Community’s Medicines Regulatory Harmonization initiative

“…• In the first paper of the Collection [15], individuals who have been involved with the program since the beginning explain how the initiative started.…”

Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

“…When the EMA was founded, its Secretariat consisted of only 16 people. The current structure of the EAC MRH initiative, which appears to contain multiple levels of hierarchy and a large number of individuals [2], may hamper its ability to make decisions quickly and respond to problems in an agile manner. Perhaps, in establishing the planned EAC Medicines Agency, the EAC can reduce bureaucratic barriers to action.…”

“…In the final article in this Special Collection in PLOS Medicine about the East African Community (EAC) Medicines Regulatory Harmonization (MRH) initiative [1][2][3][4], we, a group of authors who have had no involvement in the EAC MRH's work to date, provide an independent perspective on the program's work thus far and its plans for the future. The initiative's goal is to improve access to essential medicines in East Africa by simplifying the process of registering medicines and increasing the speed at which registration applications are reviewed while ensuring that only high-quality medicines are approved.…”

“…Dr Grignolo then invited us to contribute, as a team of coauthors with rich and varied experience in regulatory harmonization. We were provided with drafts of the other articles in the Special Collection [1][2][3][4], but otherwise, this perspective was written without input or influence from the other authors or from the EAC MRH initiative or its partners, including the Bill & Melinda Gates Foundation. Information about each author's background can be found in S1 Text.…”