Japan Continues to Update its Drug Regulations with a New Report on RX-to-OTC Switches

As discussed in our recent news briefs, Japan is initiating a number of regulations to improve its drug market including increasing novel drug reimbursement, expediting its fast-track approval system further (Sakigake), etc. In late December, the Japanese government issued a report that will decrease the time for RX drugs to become OTC products and also relax some of the burdensome requirements. If a certain foreign drug had changed its status to OTC in at least 2 foreign countries by the end of 2023, it will be eligible to switch status in Japan within 3 years (2026).

Before this paper was issued, there has been a tedious dual-step switch approval process including evaluation by both the MHLW and the Pharmaceutical Affairs and Food Sanitation Council. The report recommends that the MHLW streamline its switch review and evaluation process. For future switch applications starting in 2025, it is recommended that the time from the application process to approval, be shortened further to 2 years. There are over 75 drugs that can be bought overseas as OTC products which cannot be purchased in Japan.

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.