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
While RWE is fairly prevalent for US and EU drug companies in their home markets, this has not been the case in Japan. However, according to a recent McKinsey article, this will change in the near future and become a more common... Read More
On June 1, 2022, Japan’s PMDA‘s Medical Device Quality Control and Safety Measures Department issued an administrative communication called the “Documents to be submitted when applying for a QMS conformity inspection.” Administrative documents with the same QMS content have been published for some time, but this latest... Read More
In the past, Japan has adjusted drug prices every two years. However, in 2022, the Central Social Insurance Medical Council known as Chuikyo had its first off-year re-pricing. In 2023, Chuikyo will have its second off-year repricing which will take effect in... Read More