In late December, the MHLW announced an update to its Sakigake fast-track registration system. In the past, for an innovative drug to be eligible for the Sakigake system, it had to be either filed in Japan at the same time it was filed in the West or filed in Japan first. To qualify, the drug submission needed to be made within 30 days of the first filing. With this new update, the MHLW has extended the 30-day time period to 90 days. Also, if there is a time difference between the drug submission and acceptance date, the time clock can start on the acceptance date. Given this time extension for Sakigake, foreign drug companies should try harder to initiate registration in Japan simultaneously with drug registration in the West. While large drug companies have their own Japan teams to do this already, small to mid-sized drug and biotech companies looking to get their product into Japan may want to start their Japan partnering and licensing plans earlier.
In addition, in late December, the Japanese authority initiated a new forum to discuss how to better facilitate the development of innovative drugs in Japan. One of the main goals of the Forum is to set up a new ecosystem where drug manufacturers can see a positive return on invested capital. One idea to jump start drug development in Japan is to set up “an advanced drug institute” to facilitate better communication between researchers, start-up drug companies, and investors. The Forum, made up of both public and private members, will meet monthly and hopes to develop policies for Japan to reclaim its new drug development leadership.
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.
Source used in the article: https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/140729-01.html