Drug regulatory harmonization in the Association of Southeast Asian Nations: Is it time for an ASEAN medicines agency? A policy review

Access to medicines remains elusive in low- and middle-income countries, including those belonging to the Association of Southeast Asian Nations (ASEAN). Drug regulatory harmonization has been seen as a way to increase medicine access by reducing drug costs and improving regulatory efficiency and re...

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Bibliographic Details
Published in:	Clinical epidemiology and global health Vol. 28; p. 101649
Main Authors:	Feng, Katherine, Miranda, Adriana Viola, Obnial, Joseph Christian, Ebhodaghe, Ibhate Destiny, Lucero-Prisno, Don Eliseo
Format:	Journal Article
Language:	English
Published:	Elsevier B.V 01-07-2024 Elsevier
Subjects:	Access to medicines ASEAN drug regulatory harmonization Health care Medicines National regulatory agency Health care ASEAN National regulatory agency Medicines drug regulatory harmonization Access to medicines
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Summary:	Access to medicines remains elusive in low- and middle-income countries, including those belonging to the Association of Southeast Asian Nations (ASEAN). Drug regulatory harmonization has been seen as a way to increase medicine access by reducing drug costs and improving regulatory efficiency and reliability in the region. This paper aims to review the various harmonization initiatives of ASEAN and evaluate the potential benefits of an ASEAN Medicines Agency, the challenges for regional harmonization, and recommendations towards achieving these goals. Although several initiatives have been started decades prior, the most current initiatives include the ASEAN Pharmaceutical Regulatory Policy and the subsequent adoption of the ASEAN Pharmaceutical Regulatory Framework in 2022 and 2023, respectively. Despite these efforts, several challenges remain, such as a longer regional decision-making process, the highly individualized implementation of initiatives and disparity in laboratory and regulatory capacity between member states, and the complexities of Halal certification. ASEAN must take advantage of its strengths as a region, ensure mutual cooperation of its members, and utilize existing partnerships locally and internationally. Furthermore, a central ASEAN Medicines Agency may help further facilitate these initiatives. While significant progress has been made by member states, a consolidated body, such as an ASEAN Medicines Agency, may assist in speeding up harmonization efforts in the region which may ultimately lead to equitable access to medicines.
ISSN:	2213-3984 2213-3984
DOI:	10.1016/j.cegh.2024.101649