Japan has been very apprehensive about the so-called “drug loss” for its citizens. Many new foreign biotech companies seem to be declining Japan’s entrance due to limited reimbursement pricing mechanisms for expensive new products, especially for drugs for children, rare, and intractable... Read More
The PMDA has released a list of new medical devices approved from April to September 2022. This updated list was published on the PMDA website on December 28, 2022. Please click on the link below for details. 000249403.pdf (pmda.go.jp) This latest version... Read More
Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than 8,000 clinical trials in the West. Please note that... Read More
Over the last 3 years, many AI healthcare products have been approved in the West. However, this has not been the case in Japan. AI healthcare approvals in Japan have been difficult to obtain and experienced a very slow approval process. Given... Read More
In our May newsletter, we mentioned that in July, Japan would start allowing online submissions. At that time, online submissions of new drugs, new medical devices, improved medical devices with clinical data, IVDs for new products, and IVDs with clinical data were acceptable. Now, as of... Read More
A recent study by a research department at the Japan Pharmaceutical Manufacturer Association (JPMA) outlines how many Japanese and foreign drug companies are not increasing (and in some cases decreasing) their investment and focus in Japan’s drug market. One of the many... Read More
Over the last few months, Japan has upgraded regulations for labeling for medical devices and pharmaceuticals. In mid-September, Japan promulgated new regulations for regenerative products outlining the labeling requirements on containers for – 1. individual unit packaging, 2. the unit of packaging... Read More
Last month, we reported that the Japanese MHLW has outlined a new accelerated pilot system for SaMD products. In late October, the MHLW working group for SaMD products met with 3 groups – 1. the Japan Digital Health Alliance, 2. the Japan... Read More
In mid-October, the Japanese government’s healthcare digital transformation group met to revise reimbursements and increase reimbursements in the digital space. The government hopes to increase cost-effectiveness through digital medical fee revisions. The government has 3 targets including – 1. implementing medical reimbursement... Read More
On September 2, the Japanese MHLW outlined a new accelerated pilot system for SaMD products. Japan already has a priority system called Sakigake, but this system has four main criteria and is not focused on SaMD products. This new pilot system only... Read More