Eddie HP Tan 1, James Leong 1, Srinivasan Kellathur

1 Centre of Regulatory Excellence, Duke-NUS Medical School, National University of Singapore, Singapore
2 Roche Singapore Technical Operations, Singapore

ACTO 2025 in Singapore delivered 2 high-powered sessions on Day 2 of the conference, focusing on regulatory matters. In Regulatory Session 1 chaired by Dr Yoshiaki Maruyama (PMDA, Japan), Prof Dr Taruna Ikar (Food and Drug Authority, Indonesia) opened with a keynote lecture on the newly established Regulatory Framework of Advanced Therapy Medicinal Products (ATMP) in Indonesia. Valuable insights and regional regulatory updates were shared by regulators and regulatory experts from Japan, Thailand, Singapore, Taiwan, Italy and Malaysia. The presentations for Japan and Taiwan highlighted dual-track approaches, risk-based regulation with conditional approval pathways and robust research support consortia, and showed the continued commitment to facilitate access to ATMP innovations. The regulators from Thailand, Singapore, and Malaysia showcased their respective frameworks
integrating international standards, GMP certification, and early-stage developer consultations, emphasizing harmonization and patient safety. The European approach mandates centralized authorization for ATMPs across the European Commission member countries, continuous pharmacovigilance, and employs tools like PRIME and hospital exemptions for early access.

Chaired by Adj Asst Prof Srinivasan Kellathur and Asst Prof Eddie Tan, the Regulatory Session 2 brought back the regulatory experts, namely Mrs Tri Asti Isnariani (Indonesian FDA), Dr Yoshiaki Maruyama (PMDA, Japan), Mr Morakot Papassiripan (Bureau of Drug Control of Food and Drug Administration, Thailand), Ms Christine Ho (HSA, Singapore), Ms Chia-Ping Liu (Taiwan FDA, Taiwan), Dr Maria Cristina Galli (formerly Istituto Superiore di Sanita, Italy) for a panel discussion. The exchanges examined regulatory approaches across Asia and Europe in advancing frameworks for regenerative medicine and advanced therapy medicinal products (ATMPs). Japan’s conditional approval system demonstrates innovation but requires further adaptation, while Thailand and Indonesia are building internationally aligned structures emphasizing early consultation and expanded GMP certification. Singapore employs a flexible, risk-based model supporting both clinical and hospital-based applications. Discussions on patient access highlighted the growing role of hospital exemptions in Europe, offering controlled yet affordable pathways. Experts emphasized that sustained regulator–developer dialogue, regional harmonization, and proactive industry engagement are essential to ensure safe, efficient, and innovative ATMP development.