On April 7, 2026, Beijing health authorities released a policy package with 32 measures to support innovative drugs and medical devices across the full lifecycle, from R&D to clinical use. Key actions include improving clinical trial infrastructure, accelerating regulatory review, and expanding manufacturing and reimbursement. The policy also promotes faster hospital adoption and introduces a dual-track reimbursement model, which combines public and commercial insurance to improve patient access. A strong emphasis is placed on AI integration, including better use of healthcare data and digital tools. This policy package aims to strengthen Beijing’s position as a life sciences hub by improving regulatory efficiency, especially for innovative products.
In Singapore, the electronic Common Technical Document (eCTD) format has been officially accepted for regulatory dossier submissions since April 1, 2026. Under the new framework, drug and medical device companies may submit dossiers via the eCTD portal using eCTD version 1.1, which now serves as the national standard. Supporting technical materials will be available online to facilitate real-time validation. While traditional non-eCTD formats will still be accepted for now, the Health Sciences Authority (HSA) strongly promotes the transition to eCTD. The eCTD format, aligned with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use specifications, enables structured electronic submission of regulatory information. Its adoption is expected to reduce reliance on physical media such as CDs and DVDs while improving lifecycle management of therapeutic product dossiers. This update marks a significant step toward digitalizing regulatory processes in Singapore.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.