Drug reimbursement is a key issue in Japan, especially as the country wants to promote innovative therapies and reduce the drug lag/loss there. Over the last few months, the MHLW, Central Social Insurance Medical Council (Chuikyo), the Japan Pharmaceutical Association, and other... Read More
Singapore’s Health Sciences Authority (HSA) has strengthened international regulatory collaboration through two Memoranda of Understanding (MOUs) signed during the 16th International Conference on Medical Regulation 2025. On September 4, the HSA signed an MOU with Australia’s Therapeutic Goods Administration (TGA) to facilitate... 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
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation... Read More
Japan is the third-largest medical device market in the world, so it warrants important attention by medtech companies planning their global commercial strategy for new products. But for foreign device firms the country is not an easy one in which to make... Read More
On August 26, the MHLW released its FY2026 budget, which showed an increase of 550 billion yen from the previous year. The total 2026 budget is planned for about 35 trillion yen. There are many goals of the increased budget, including expediting... Read More
Japan’s Ministry of Health, Labor, and Welfare (MHLW) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) celebrated the tenth anniversary of their Memorandum of Cooperation with Korea’s Ministry of Food and Drug Safety (MFDS). For the last ten years, the agencies have... Read More
Over the past year, Japan’s regulatory and reimbursement environment for medical devices has been rapidly changing. These changes illustrate the government’s ongoing commitment to healthcare innovation, effective reimbursement mechanisms, and expanded oversight under the updated Pharmaceutical and Medical Device Act (PMD Act).... Read More
In Japan, recruiting patients for clinical trials is not an easy process. Advertising regulations for investigational trials, under Article 68 of the PMD Act, are restrictive and follow the same rules as advertising regulations for already approved drugs. This has made it... Read More