By Nobuyuki Yamagata, Senior Consultant, PAREXEL® Consulting & Yoshinori Shinoki, Senior Director, PAREXEL® Consulting
On September 7th, MHLW (Japan’s Ministry of Health, Labor and Welfare) announced the 2018 deadline to apply for “SAKIGAKE” designation.
“SAKIGAKE” (“Pioneer” in Japanese) is a unique regulatory designation that aims at shortening the premarket review period for certain products by designating such products during the early stages of development, and providing prioritized health authority consultation services and premarket technical review. Eligible products must be innovative, new medical products that satisfy certain criteria, such as severity of intended indication.
By taking advantage of the benefits offered by “SAKIGAKE”, the target review period for the designated products can be reduced to as short as 6 months, which is half the typical review period of 12 months for new pharmaceutical products.
The major criteria for “SAKIGAKE” designation are:
- Having developed the product first in Japan and planning to submit an application for approval (desiring to have PMDA consultation from the beginning of early product development activities)
- Demonstrating prominent effectiveness (i.e., is there a radical improvement compared to existing therapy?) should be expected based on the data on mechanism of action, non-clinical studies, and early phase of clinical trials (phase I to II)
As described above, “SAKIGAKE” offers huge regulatory advantages to pharmaceutical and biotech companies that have cutting edge products for unmet medical needs.
The deadline for “SAKIGAKE” applications is November 30, 2018. For more information on the “SAKIGAKE” designation, visit the MHLW website for more details. PAREXEL can help clients navigate the “SAKIGAKE” process, to promote the successful development, submission and approval of medically necessary products for Japan.