Japan reduces drug prices every two years or more recently yearly. As announced on March 5 in the MHLW‘s gazette, starting April 1, drug prices will be reduced by about 4.7% for about 13,000 products including 7,000 oral drugs, 3,600 injectables, 2,000... Read More
In an effort to improve the Japan drug lag problem, the Japanese government plans to initiate several programs to simplify and optimize its drug clinical trial program. First, there are too many systems for clinical trials in Japan including the PMD Act,... Read More
IVDs, drugs and medical devices have different reimbursement pathways in Japan. Normally, for all these paths, a reimbursement application is submitted after product approval. Reimbursement is then normally determined within 3-6 months. However, the MHLW is allowing some companies to have a pre-reimbursement meeting. For... Read More
The Ministry of Health, Labor, and Welfare (MHLW) in Japan plans to start a new initiative aimed at boosting the skills of inspectors working under the Good Manufacturing Practice (GMP) guidelines. This initiative will involve sharing inspection reports from across the nation,... Read More
Submission of applications to the Japanese authority now mandates usability engineering. The international standard IEC 62366-1, governing usability engineering in medical device development, transitioned into a JIS standard in 2019 and was updated as JIS T62366-1:2022 in February 2022. JIS T 62366-1... Read More
Japan has always been a good orphan drug market with high reimbursement and oftentimes government financial support for development. However, in the past, it was not flexible on designation unless 3 criteria were met – 1. the drug had to treat fewer... Read More
As discussed in our recent news briefs, Japan is initiating a number of regulations to improve its drug market including increasing novel drug reimbursement, expediting its fast-track approval system further (Sakigake), etc. In late December, the Japanese government issued a report that will... Read More
During the last year, we have outlined the steps the PMDA is taking to expedite registration for Software as a Medical Device (SaMD). Besides expanding its SaMD review staff and offering more SaMD consultation sessions, the PMDA presented on January 22nd in... Read More
In late December, the MHLW announced an update to its Sakigake fast-track registration system. In the past, for an innovative drug to be eligible for the Sakigake system, it had to be either filed in Japan at the same time it was... Read More
Japan’s PMDA will open its first overseas office in Bangkok in 2024 or at the latest by March 2025. The new PMDA office will interact with Southeast Asian countries and hopefully improve their knowledge of Japanese requirements. China removes tariffs on 62... Read More