On December 30, 2025, China’s National Medical Products Administration (NMPA) issued Announcement No. 134, which is expected to strengthen the oversight of local contract drug manufacturing. The regulation took effect immediately and provides a one-year rectification period. Companies that fail to comply may face... Read More
In January 2026, Japan’s Ministry of Health, Labour and Welfare (MHLW) issued a new notice clarifying the regulatory procedures for changes to raw materials used in medical devices. The notice replaces the prior guidance from 2013 to determine when a raw material... Read More
India’s Central Drugs Standard Control Organisation (CDSCO) has announced that product applications will be rejected if applicants fail to respond to official regulatory queries within 90 days of receiving the first reminder. The CDSCO aims to clear long-pending applications across drugs, medical... Read More
On January 7, 2026, China’s National Medical Products Administration (NMPA) announced measures to expedite the approval of drugs already approved outside of China that are urgently needed in clinical practice. The Centre for Drug Evaluation (CDE) will assess the clinical demand of... Read More
In late December, Malaysia’s Ministry of Health (MOH) announced a new requirement regarding the use of a FarmaTag hologram security label on drug products. The measure is intended to strengthen labeling and authentication requirements. Also, it will enhance safeguards against counterfeit medicines and improve... Read More
Thailand’s Food and Drug Administration finalized its Medical Device Labeling Regulation (B.E. 2568) on December 22, 2025. The regulation consolidates prior fragmented rules into a single framework. Mandatory compliance needs to start by June 20, 2026. The new rules clarify labeling content,... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) is advancing a “full-cycle regulatory system” for rare disease drugs to reduce delays and improve patient access. Rare disease drug development is often hindered by small patient populations and limited clinical data, making trial-and-error... 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
India’s Department of Biotechnology (DBT) is developing plans to introduce “regulatory sandboxes” for the pharmaceutical sector to fast-track approvals and shorten drug development timelines. A sandbox would allow innovators to test drug products with more relaxed regulatory requirements. The goal of this initiative... Read More
In December 2023, Japan introduced important regulatory changes that significantly reshape global drug development strategies. Under new guidance issued by Japan’s Ministry of Health, Labour and Welfare (MHLW), drug developers will now be allowed to include Japanese subjects in their multi-regional clinical... Read More