[ASEAN] Key Regulatory Advances in Therapeutic Product Registration & Authorisation

This episode delves into critical regulatory developments impacting the therapeutic product landscape in ASEAN, including updates on Chemistry, Manufacturing, and Controls (CMC) dossier requirements, authorisation frameworks, and drug approval processes.Key updates include Singapore's Health Sciences Authority mandating the use of eCTD version 1.1 for dossier submissions effective April 1, 2026, along with new requirements for quality defect declarations starting June 1, 2026. Additionally, Indonesia's BPOM is advancing conditional marketing authorisation for vaccines post phase 1 and 2 clinical trials, balancing innovation with safety and public trust.On the financial regulatory front, Singapore’s Monetary Authority has refined capital treatment rules and is developing AI risk management guidelines, emphasizing operational risk and fair customer dealings. Malaysia’s Governor highlighted the need for integrated policies and enhanced cyber resilience in central banking.For more information, visit the Carver Agents website.Articles mentioned:IAIS concludes multi-year cycle of Holistic Framework implementation assessmentsDelivering on the Insurer’s Promise - Keynote speech by Mr Marcus Lim, Assistant Managing Director, MASRegulatory Updates on Therapeutic Product Registration (1 April 2026)Governor's Keynote Address at the Central Banking MeetingsKepala BPOM Sampaikan Gagasan Vaksin Maternal di Harvard Medical SchoolSummary report on authorisation – Lynkuet®Kurzbericht Zulassung – Lynkuet®Public Consultation: Initial Access List