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... Read More
Singapore’s Health Sciences Authority (HSA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) signed a Memorandum of Cooperation in Tokyo on April 20, 2026. The agreement aims to bring the two regulators closer together in how they oversee drug products. At... Read More
Singapore’s Ministry of Health (MOH) has released new “Cybersecurity and Data Security Essentials” guidelines to support the rollout of the Health Information Act (HIA). The guidelines set out baseline requirements for healthcare providers handling patient data. They will be introduced in phases... Read More
In late January, Singapore’s Health Sciences Authority (HSA) published an updated guidance on defect reporting and recall procedures for therapeutic products in Singapore. The new guideline applies to therapeutic products, including biologics, as well as cell, tissue, and gene therapy products. It outlines what... Read More
On February 13, 2026, the Health Sciences Authority (HSA) released the outcome of its public consultation on a proposed “regulatory sandbox” for AI software as a medical device (AI-SaMD). The sandbox would exempt certain AI-SaMDs developed by public healthcare institutions from product... Read More
Singapore’s Health Sciences Authority (HSA) has a structured framework for the submission and management of Drug Master Files (DMFs) to support the registration of therapeutic products. Under the DMF system, manufacturers can submit confidential information on drug components while enabling drug product... Read More
On January 15, Singapore’s Health Sciences Authority (HSA) and the Indonesian Food and Drug Authority signed a Memorandum of Understanding (MoU) to improve regulatory cooperation. Both agencies have obtained the World Health Organization (WHO) Listed Authority status, which confirms that they have met... Read More
The Singapore Health Sciences Authority (HSA) has introduced regulatory updates to help clarify and streamline the registration of Therapeutic Products, effective January 16, 2026. Key updates include: A new pathway for submitting Standard Essential Medicines as a Generic Drug Application (“GDA”) for... Read More
Approximately 50% of global clinical trials are conducted in the Asia Pacific region today. The clinical trial landscape of Asia has been expanding beyond China in recent years. Although over 60% of the clinical trials in the region were initiated in China... Read More
The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) and Singapore’s Health Sciences Authority (HSA) have established a new “Regulatory Innovation Corridor” to speed up patient access to innovative healthcare solutions. Companies will be able to work with both regulators at the... Read More