Please feel free to contact us to obtain more information about Japan DMF. Drug component manufacturers of APIs, excipients, and drug packaging materials who want to protect their intellectual property and manufacturing processes may want to pursue a Japanese Drug Master File... Read More
On July 10, the Japanese MHLW outlined a plan to increase the number of products allowed to apply for Orphan Drug Designation (ODD) and permit this designation earlier in the drug development process. Currently, Japan only accepts orphan drugs that are for... Read More
While much of the Western world has initiated regulations and reimbursement for SaMD products, Japan is still grappling with this product category. The number of SaMD product approvals in Japan dwarfs the number of approvals in the West. As Japan gets more... Read More
Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. One of the key issues in getting drug approval in Japan is to meet Japanese GMP standards. To register a drug in Japan, foreign drug... Read More
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