On June 16, the PMDA steering committee announced that in April 2024 or shortly thereafter, the PMDA will open offices in the US and Southeast Asia. Likely locations for these offices are Washington DC and Bangkok, Thailand – although this is not... Read More
While Japan is a huge drug market with decent reimbursements, in many ways it is not progressing as quickly as many developed foreign drug markets. In an effort to jump-start more drug activity in Japan, in early July, the Japanese MHLW will... Read More
Normally, every two years in April the Japanese government revises drug prices. Recently, such revisions have occurred annually or in so-called “off years”. Drug price revisions went into effect on April 1st, 2023. Drugs in Japan with price variances between their market... Read More
Japan has been slow to approve SaMDs but hopes to finalize its registration system for these products in 2024. On May 29, after a working group session that included the PMDA and Chuikyo (Japan’s reimbursement agency) to discuss SaMD registration, a guidance... Read More
On March 9, 2023, a new regulation for ensuring cyber security was issued in the Essential Requirements Criteria in Japan. The Essential Requirements Criteria’s Article 12 already had 2 clauses, but clause 3 on cybersecurity has now been added. In short, medical... Read More
Normally, drug approval in Japan is based on clinical trials done under Japanese GCP requirements. On the other hand, clinical research not initially used for drug registration is called Specified Clinical Research (SCR). SCR is regulated by the Japanese Clinical Research law.... Read More
Up until recently in Japan, most drug applications, informed consent forms, and other drug documents needed to be in hard copy with original personal stamps or signatures. On March 30, Japan’s Ministry of Health, Labor, and Welfare (MHLW) authorized the use of... Read More
Currently, while digital health is very prevalent in the West, it is still at an infant stage in Japan. However, this is changing now. In 2020, a startup in Japan called Cure Up received regulatory approval for its nicotine addiction treatment. Also,... Read More
At a March 13 PMDA meeting, the priority review time for SaMD products was set at 6 months. SaMD products with strong effectiveness will enjoy SaMD priority review if the SaMD product is submitted first in Japan or simultaneously with other global... Read More