Japan Continues to Improve Market Access for Drugs

As noted in previous news briefs, there has been a drug lag in Japan which the Japanese government is trying to shorten. In an effort to improve the overall drug market, the Japanese MHLW has called for an increase in the number of times each year newly registered drugs will get drug reimbursement. As of today, the Japanese Pharmaceutical Affairs and Food Sanitation Council (PAFSC) First and Second Committees on drugs has only four sessions per year including one session each in January/February, April/May, July/August, and October/November to review drug applications and send their feedback to the MHLW. Formal MHLW drug approval is granted one month after each PAFSC meeting and thus occurs in March, June, September and December.  After drug approval, the Japanese reimbursement body (Chuikyo) will then allocate reimbursement within 90 days. So, there are 4 times a year for drug approvals and 4 times a year for reimbursement.

Under the new MHLW plan, starting January next year, the PAFSC will respond to the MHLW, and approval will be granted in only 3 weeks (21 days), and there will be 7 rounds of Chuikyo drug reimbursement. In other words, products reviewed and approved in January will be reimbursed in February, and products reviewed and approved in February will be reimbursed in March. Similar reimbursement timelines will be done for drugs reviewed and approved in April, May, July, and August.  Thus, for these months there will be 6 reimbursement schedules, instead of 3, and they will occur earlier.  Drugs reviewed and approved in October/November will be put in one program and receive reimbursement in December. This results in a total of 7 drug reimbursements in the new year. Thus, the MHLW has made efforts to increase the speed of drug approvals and reimbursements. In addition, some at the MHLW want to have more “re-pricing” schemes for very innovative drugs during the year too.

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.