Weekly ASEAN Regulatory Digest
Hi,
Welcome to the Weekly ASEAN Regulatory Digest by The Regulatory Compass.
I hope you will find in this edition and future ones the resources you need to maintain a smooth and effective regulatory watch.
The TRC team and I remain at your disposal.
This week
Singapore
HSA mandates eCTD v1.1 for therapeutic product submissions
The Health Sciences Authority (HSA) has officially adopted the electronic Common Technical Document (eCTD) format as the national standard for regulatory dossier submissions since April 1, 2026. Companies submit via the eCTD portal using version 1.1, aligned with ICH specifications, replacing reliance on physical media like CDs/DVDs while allowing transitional non-eCTD formats. Technical conformance guides and validation tools support real-time checks and lifecycle dossier management.
Implications:
Life sciences firms gain faster, paperless processing for drugs and devices; prioritize eCTD training to avoid delays. Regional reliance pilots with Malaysia/Indonesia enhance medtech approvals by 30-50% via mutual recognition.
Malaysia
MDA-HSA medtech regulatory reliance pilot advances
Malaysia’s Medical Device Authority (MDA) and Singapore’s HSA extended their successful pilot for Class B-D device mutual recognition, initiated December 2025, reducing review timelines significantly. The framework harmonizes assessment criteria, allowing reliance on partner approvals.
Implications:
Medtech companies see accelerated market entry across ASEAN; prepare dual dossiers for pilot eligibility. National DURC policies from WHO-aligned workshops strengthen biosafety oversight.
Indonesia
BPOM enables conditional vaccine authorizations
Indonesia’s BPOM now permits conditional marketing authorizations for vaccines post-phase 1/2 trials, expediting access amid public health needs while mandating Phase 3 data. This builds on recent Singapore MoU for cross-border regulatory cooperation.
Implications:
Vaccine developers accelerate ASEAN launches; ensure robust safety data. MoU facilitates shared expertise in medical products.
China
Beijing policy package boosts innovative drugs/devices
On April 7, 2026, Beijing authorities unveiled 32 measures supporting full lifecycle of innovative therapies, including accelerated reviews, AI data tools, clinical infrastructure, and dual-track reimbursement. NMPA also issued 26 new device standards effective 2027-2029.
Implications:
Multinationals leverage IITs for early data; align manufacturing for reimbursement. Positions China as R&D hub.
South Korea
MFDS approves first domestic CAR-T therapy
The Ministry of Food and Drug Safety (MFDS) cleared Curocell’s Rimqarto (anbalcabtagene-autoleucel) on April 29, 2026, as Korea’s inaugural homegrown CAR-T for relapsed/refractory large B-cell lymphoma post two prior lines.
Implications:
Local biotech gains pricing/reimbursement edge; global firms eye partnerships. Bio Korea 2026 spotlights oligo innovations.