A push by Japan to establish an emergency pharmaceutical approval system modeled on that of the United States is moving forward, with legislation to speed the distribution of drugs and vaccines needed to prevent outbreaks of infectious diseases and other public health... Read More
Despite generally reduced medical insurance in Japan for medical devices, the Japanese government may increase coverage of some medical device software products in 2022. The Japanese medical device industry has proposed to the reimbursement arm of the PMDA – Central Social Insurance Medical... Read More
Driven by the urgent need to speedily combat the COVID-19 epidemic, Japan plans to ease its famously stringent requirements on clinical trials of vaccines and other essential drugs, laying the groundwork for rapid approval when emergency need is deemed to be overwhelming.... Read More
Japan medical device reimbursements will generally go down slightly in 2022, but some new technologies with clear benefits will not. Discussions on reimbursement revisions in 2022 are being held by the Insurance Medical Material Special Subcommittee of the Central Social Insurance Medical... Read More
Spurred by the harmonization of safety requirements on drug development by regulators in the United States and Europe, Japan’s drug regulators are tightening requirements on the development of new pharmaceuticals. By next year, for example, all products used in clinical trials must... Read More
Eager to encourage the development within its own borders of pharmaceuticals to meet urgent health needs of its people, Japan’s health authorities have begun discussions on establishing an emergency approval system modeled on that of the United States. While a legal pathway... Read More
Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. This article was originally published on MedTech Intelligence. Japan is still the third largest medical device market in the world, after the United States... Read More
The Japanese Ministry of Health, Labor and Welfare issued a notice on September 29, 2021 that stated that Japan has decided to formally start accepting MDSAP reports for medical devices and IVDs as part of the Japanese QMS process for product registration... Read More
A working group established in April by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is tackling the knotty issues of how best to employ real-world data (RWD) in formulating regulations of orphan drugs and other novel treatments under development for patient populations... Read More
Japan’s health agencies in September released a set of goals for encouraging the development of life-saving drugs, speeding clinical trials, and encouraging medical research and technological advances. Developed by the Ministry of Health, Labor, and Welfare (MHLW), the strategy document, the Pharma... Read More