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
For medical device approvals in Japan, the Japanese PMDA must do a GCP compliance inspection of the clinical data with the applicant during a face-to-face meeting. This in-person inspection is normally done in a conference room at the PMDA. On August 24th, an... Read More
The recent amendments of the Japanese Act on the Protection of Personal Information (AAPI) have implications for healthcare businesses. According to the amendments, companies/health institutions are not allowed to transfer personal data overseas. Transfer of data outside of Japan is only permitted under special circumstances.... Read More
In order to facilitate the development of new drugs, Japan’s Ministry of Health, Labor, and Welfare (MHLW) is seeking an increased budget for its Orphan Drug Designation program. In order to obtain this designation in Japan, orphan drugs need to fulfill certain... Read More