According to the recent Medical Facility Act in Thailand, telemedicine is now allowed and becoming more pervasive. Hospitals and clinics can diagnose, prescribe, and send out electronic prescriptions after a video call with a doctor is completed. Also, telepharmacy now permits a... Read More
On July 7, Japan’s PMDA published its GMP annual report for 2024. Japan’s PMDA has reported that many foreign drug companies are not meeting Japan’s GMP standards. In 2024, there were 126 on-site GMP inspections and 2,049 desktop GMP inspections. These figures... Read More
The Taiwan Food and Drug Administration (TFDA) has recently promulgated updated technical guidance on artificial intelligence-based medical devices, which came into effect on August 14, 2025. The new guidelines will replace the 2023 edition and incorporate additional clarification and detailed requirements for... Read More
China’s 2025 revision of the National Reimbursement Drug List (NRDL) has been the most competitive in history, with a record-setting number of candidates qualifying for the first round of formal review. Through mid-August 2025, there are more than 300 drugs for new... Read More
The Thai FDA announced updated renewal procedures for Class 2, 3, and 4 medical devices, which came into effect on July 22, 2025. Renewal applications must be submitted on an annual basis, between October 1 and December 31. Devices that were originally... Read More
India has released a draft bill calling for greater accountability from clinical trial sponsors and contract research organizations (CROs). Companies will need to pay damages and treat participants who suffer from injuries during any trials. If the trial sponsors do not comply, companies would face a... Read More
The National Medical Products Administration (NMPA) of China has issued revisions to its clinical trial policies in an effort to shorten drug development timelines and encourage innovation. The revised guidelines, which became effective on September 2, 2025, are expected to reduce approval... Read More
India’s Union Health Ministry has suggested amending the New Drugs and Clinical Trial Rules, originally issued in 2019, to simplify approvals and encourage pharmaceutical innovation. The modification in the draft would permit drug companies to conduct some of the bioavailability and bioequivalence... Read More
A draft bill has been introduced in Korea to increase the scope of devices that can receive a designation as “innovative medical devices“. Innovative devices are those that would enhance the convenience and quality of diagnosis and treatment. At present, only devices with enhanced safety... Read More
Malaysia’s Ministry of Health (MOH) has recently announced that it will factor real-world evidence (RWE) in its decision-making for the inclusion of drugs into its national formulary – the “Blue Book.” This change signals a shift toward moving beyond reliance on clinical trial data alone and toward... Read More