Regulations Across ASEAN

Covering CMC Dossier, Elinzanetant, Authorisation, Drug Approval, Therapeutic Product Registration. Explore pivotal regulatory updates in CMC dossier standards, Elinzanetant authorisation, drug approval pathways, and therapeutic product registration across ASEAN markets. Insights include digital dossier submissions and conditional vaccine authorisations.

Show Notes

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:
  1. IAIS concludes multi-year cycle of Holistic Framework implementation assessments
  2. Delivering on the Insurer’s Promise - Keynote speech by Mr Marcus Lim, Assistant Managing Director, MAS
  3. Regulatory Updates on Therapeutic Product Registration (1 April 2026)
  4. Governor's Keynote Address at the Central Banking Meetings
  5. Kepala BPOM Sampaikan Gagasan Vaksin Maternal di Harvard Medical School
  6. Summary report on authorisation – Lynkuet®
  7. Kurzbericht Zulassung – Lynkuet®
  8. Public Consultation: Initial Access List

What is Regulations Across ASEAN?

Regulatory news, updates, and insights for countries in the ASEAN region presented by the Carver Agents team

Welcome to Carver's ASEAN Regulatory Updates for April 05, 2026.

The Monetary Authority of Singapore announced the introduction of revised Notice 133 on Valuation and Capital Framework, effective March 31, 2026. Key refinements include a new capital treatment for infrastructure investments, adjustments to the treatment of structured products, and equity counter-cyclical adjustments. The Monetary Authority of Singapore is also conducting ongoing consultations on third party risk and operational risk management guidelines. Emphasis has been placed on fair dealing and improving customer communication. Additionally, the authority is developing artificial intelligence risk management guidelines and support platforms.

Effective April 1, 2026, the Health Sciences Authority of Singapore has mandated the use of eCTD version 1.1 as the official standard for dossier submissions related to therapeutic product registration. From June 1, 2026, applicants must provide an official letter declaring no known quality defects in the Chemistry, Manufacturing, and Controls package. Applicants are required to submit dossiers via the official portal using the SG-HSA eCTD version 1.1 and refer to updated guidance documents for detailed submission requirements.

In Malaysia, the Governor delivered a keynote address at the Central Banking Meetings emphasizing that central banks must evolve from being solely stewards of stability to architects of resilience. The Governor called for the adoption of integrated policy frameworks that recognize structural economic forces, strengthening cyber resilience and governance around artificial intelligence and data risks, and enhancing coordination across monetary, fiscal, structural, and prudential policies.

Indonesia's National Agency of Drug and Food Control, known as BPOM, is promoting a conditional marketing authorization approach for vaccines following phase 1 and 2 clinical trials. The agency emphasizes balancing innovation, safety, and public trust in regulatory decisions and enhancing collaboration between academia, industry, and government.

The Philippines' Technical Working Group has launched a public consultation on the Initial Access List to ensure fair and non-discriminatory access to essential digital infrastructure and services. Stakeholders are invited to submit inputs as stipulated in Rule VI of the Implementing Rules and Regulations of Republic Act No. 12234.

That wraps up today's regulatory updates. Visit carveragents.ai for more information.