The Meeting of the Assembly of South-East Asia Regulatory Network (SEARN) officially commenced today in Thimphu, Bhutan. The two-day meeting is being hosted by the Bhutan Food and Drug Authority (BFDA), Ministry of Health, with the support of the World Health Organization (WHO). This high-level event brings together regulatory leaders and stakeholders from across the South-East Asia Region to advance regulatory collaboration, convergence and reliance across the region.
Established in 2017, SEARN is a Member States-led initiative comprising all National Regulatory Authorities (NRAs) responsible for the regulation of medical products in the South-East Asia Region. The network has evolved into a dynamic platform of over 100 experts from NRAs who collaborate throughout the year to implement a shared work plan.
This year’s Assembly, held under the theme “Regulatory Excellence: Achieving Balance of Quality and Accessibility to Medical Products for All,” underscores SEARN’s commitment to strengthening regulatory systems that ensure timely access to quality-assured, safe and effective medical products for every population in the region. The Assembly will serve as a strategic platform to review progress made under the 2024–2025 SEARN Workplan; endorse the Workplan for 2025–2026, in accordance with the network’s Monitoring and Evaluation Framework and discuss and agree on the strategic directions of SEARN to support continued regulatory advancement in the region.
The meeting is bringing together over 40 participants comprising the Heads of National Regulatory Authorities of member states, Chairs of SEARN Working Groups; other members from NRAs, representatives from the World Health Organization (WHO), other development partners; representatives from public procurement agencies and the members of the Coalition of Interested Parties (CIP).
The meeting is expected to foster critical dialogue on a range of strategic priorities, including the review of pilot initiatives under SEARN’s Capacity Building Strategy and the finalization of a SEARN Memorandum of Understanding (MoU) to facilitate structured collaboration and information sharing among Member States. Additional key discussions will focus on SEARN’s engagement with international regulatory networks such as ASEAN and the International Medical Device Regulators Forum (IMDRF), as well as a review of the network’s coordinated response to Mpox, highlighting the value of regional regulatory cooperation in public health emergencies.
The Assembly will also consider the establishment of a dedicated working group on traditional medical products, reflecting growing recognition of the need for harmonized approaches in this area. Moreover, the meeting offers a platform for in-depth engagement with members of the Coalition of Interested Parties (CIP) and to initiate exploratory discussions with prospective partners, including Japan, the Asian Development Bank (ADB) and the United States Food and Drug Administration (USFDA), to broaden the network’s collaborative base.
The Assembly reflects SEARN’s overarching mission: to build trust, strengthen capacity and support NRAs in fulfilling their public health mandates by fostering collaboration over shared regulatory issues and challenges.
Tandin Wangchuk
World Health Organization Bhutan
Bhutan Food and Drug Authority