Japan has had a flurry of new drug regulations to ease their drug lag problem and make their country more conducive to innovative drugs. As mentioned last month, Japan’s PMDA is now allowing the submission of some innovative drug applications in English and will respond to English innovative drug inquiries too. Japan will also increase its budget for 2025 to bolster its first-in-human (FIH) trial system for gene and cell therapies and plans to set up a system to match innovative drugs with appropriate Japanese clinical sites. This pairing-up service will begin in several years and by 2029 it expects to help about 15 innovative drug companies per year. In addition, the PMDA plans to open its first office in the US (Washington, DC) very soon to provide Japanese regulatory and overall support for foreign drug firms with innovative products looking to enter Japan.
Besides the above, the Japanese MHLW has outlined a new policy to reduce the time for post-approval drug changes. Currently, the post-approval change period is significantly shorter in the US and EU, than in Japan. Thus, the MHLW has set up a new program for RX manufacturing changes of “moderate risk.” This new program will shorten the review period from 6 months to 40 days. This new program, which was notified on October 27, was set up as a sub-category of the existing partial change regulation. Drug manufacturers must discuss changes before sending in their change applications to the PMDA, and if there are uncertainties about whether the changes will be classified as “moderate changes,” they will need to further consult with the PMDA. Moderate changes that will be acceptable include ones that are – 1. applicable to test methods and specs for finished drugs, APIs, and excipients; 2. shelf life and storage of finished drugs and APIs; and 3. other manufacturing methods.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.