April 21, 2017
For Inquiries:
Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, MHLW
Koushin Kiyohara, Deputy Director (Ext. 2746)
Gou Yamamoto, Evaluation and Coordination Officer (Ext. 2740)
(Main) 03 (5253) 1111
(Direct) 03 (3595) 2431
Product Designation under the "SAKIGAKE Designation System"
-5 pharmaceutical products have been newly designated. Their target premarket
review period will be shortened to 6 months, half the normal period-
The Ministry of Health, Labour and Welfare (MHLW) evaluated 47 pharmaceutical products submitted for consideration for the SAKIGAKE designation concluding in November 2016. As a result, MHLW today announces its designation of the following products under the "SAKIGAKE Designation System" (hereinafter, "SAKIGAKE".)
SAKIGAKE was introduced based on key measures set forth in the "Strategy of SAKIGAKE", announced by MHLW in June 2014, and the "Japan Revitalization Strategy" (revised in 2014).
SAKIGAKE aims at shortening premarket review period for innovative new medical products that satisfy certain criteria, such as severity of intended indication, by designating such products during the early stages of development, and providing prioritized consultation services and premarket pharmaceutical affairs review.
By taking advantage of the benefits offered by SAKIGAKE*, the target review period for the designated products will be reduced to as short as 6 months, half the standard review period of 12 months for typical new pharmaceutical products.
The Designated products
| Product Name | Intended Indication(s) | Applicant Name |
|---|---|---|
| Olipudase Alfa (Genetical Recombination) | Acid sphingomyelinase deficiency | Sanofi K.K. |
| aducanumab | treatment and prevention of Alzheimer's Disease | Biogen Japan Ltd. |
| DS-5141b | Duchenne muscular dystrophy (who has a mutation of the dystrophin gene that is amenable to exon 45 skipping) |
DAIICHI SANKYO CO.,LTD. |
| SPM-011※ |
|
STELLA PHARMA CORPORATION |
| Nivolumab (Genetical Recombination) | Biliary Tract Cancer | ONO PHARMACEUTICAL CO.,LTD. |
※Boron preparation for use with the “Boron Neutron Capture Therapy (BNCT) System” designated as a SAKIGAKE product on February 28, 2017.
If the designated product is used in combination with an in vitro diagnostic (IVD) product, such IVD(s) will also be treated as a SAKIGAKE product alongside the designated product.
[Reference] The SAKIGAKE Designation System
*Under the SAKIGAKE Designation System, whole product development period will be shortened through 1) prioritized consultation services, 2) enhancing pre-application consultation and 3) prioritized premarket reviews, in addition to promotion of development through support from 4) a review partner (provided by PMDA) and 5) substantial postmarketing safety measures.