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
On September 13th, the MHLW (Ministry of Health, Labor and Welfare) issued an administrative notice requiring the display of codes (barcode display) on containers to identify medical devices and in-vitro diagnostics. Previously, the display of codes on devices was recommended, but not required. The... Read More
Last month, one of our news briefs discussed remote inspections for medical device GCP. Recently, the PMDA also issued remote GCP inspections for drugs and regenerative products. In August, the Japanese PMDA issued these guidelines in English. These guidelines advise on the... Read More
Japan’s MHLW is hoping to increase its fiscal year 2023 budget in a number of healthcare areas to promote better healthcare. An additional $3 million dollars is proposed to help cancer drug research via AI data analysis. This research is being done... Read More