The Japanese MHLW has increased its budget by over $3 billion for fiscal year 2025. The extra funding will be used to enhance the development of promising drugs and medical devices. Part of the budget will be allocated to building a stronger... Read More
In late July, China announced a new trial program, starting in August 2024 for one year, to reduce the IND review time for innovative drugs in China to 30 days. Previously, the IND review time was 60 days and if an applicant... Read More
In early August, India’s Central Drug Standard Control Organisation (CDSCO) decided to eliminate the need for local Indian clinical trials for certain drugs if they have already been approved in the EU, US, UK, Australia, Japan, and Canada. This new regulation and new... Read More
Recently, the Filipino FDA initiated a new pilot device registration system called the eServices Portal System. This announcement is under the FDA’s Advisory No. 2024 – 1089 II Pilot program. Basically, applicants for device approval need to be licensed medical device establishments with... Read More
In mid-June, the Chinese NMPA promulgated a new guideline on a trial basis to standardize inspections of device clinical trial sites. In the past, device clinical trial oversight has been somewhat lax, and these guidelines hope to improve the safety and quality... Read More
Japan’s Pharmaceutical Manufacturing Association claims that there are about 150 drugs approved in the US and Europe that are not approved in Japan. Obviously, this is to the detriment of Japan’s healthcare system. Of the drugs not available in Japan yet, about 60%... Read More
Recently, Singapore’s HSA (the Therapeutics Products Branch, Health Products Regulation Group), updated many drug regulations. For new drug applications (NDAs), generic drug applications (GDAs), and major variation applications (MAV-1), companies can expect to receive their first evaluation feedback earlier than before. In addition,... Read More
On July 18, the Japanese Ministry of Health, Labor and Welfare (MHLW) introduced new criteria for excluding certain drugs from mandatory post-marketing surveillance (PMS), traditionally required for newly approved medicines. This initiative aims to mitigate delays and reduce losses in drug availability. The MHLW informed... Read More
The Department of Health (DH) is set to enhance its medical device procurement strategy, building on the first phase implemented on June 21, 2023. The second phase of this strategy will be introduced in two stages to ensure better quality and safety... Read More
In late May, China’s CDE under the NMPA, promulgated a new program for rare diseases called the – Patient-Centered Action for Rare Disease Encouragement (better known as the Care Plan). This pilot program focuses on the “rare disease patient” and is geared... Read More