Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia

Ensuring access to essential medicines is a key objective of all health systems, and is an integral component of the progress towards universal health coverage (UHC). Despite global and national efforts to improve access and affordability of medicines, millions of people – particularly in low- and middle-income countries – still remain without access to quality-assured and affordable medicines. This study aims to contribute to existing knowledge on regulatory systems and harmonization efforts in Southeast Asia. Focusing on five member states of the Association of Southeast Asian Nations (ASEAN) – Indonesia, Malaysia, the Philippines, Thailand, an Vietnam – this study gives an overview of pharmaceutical markets and key pharmaceutical policies in the region, provides a cross-country comparison of medicines regulatory systems, and details harmonization efforts, opportunities, and challenges. The rest of the report is structured as follows. The background section provides an overview of the overall socioeconomic and health sector context in ASEAN. Part three on ASEAN pharmaceutical markets outlines the pharmaceutical sectors in the five analysis countries, including local and foreign market shares, product portfolio, and pharmaceutical policy trends. We then provide a conceptual framework for examining medicines regulation and regulatory harmonization efforts in Part four. This is then followed by a comparative analysis of the NMRAs in Malaysia, Indonesia, the Philippines, Thailand, and Vietnam, focusing on selected capabilities and outcomes in each country that have a bearing on the countries’ ability to participate in regulatory harmonization efforts. Part six on harmonization initiatives in the region then explains the range of medicines regulatory harmonization initiatives in ASEAN, identifying key opportunities and constraints. The final section concludes, and suggests viable next steps for regulatory harmonization in ASEAN.