In 2015, IDA became one of only five companies to obtain SAKIGAKE Designation (out of over 60 applicants) and remains the first and only service provider to maintain this designation on behalf of an overseas client.
In 2015, MHLW promulgated new regulations known as “SAKIGAKE” (or the “Forerunner Initiative”) that allows for dramatically accelerated regulatory pathways for drugs designated as breakthrough therapies addressing high, unmet medical needs with the additional condition that companies initiate early development and seek initial product approval in Japan.
The SAKIGAKE regulatory process is outlined below.
Benefits of SAKIGAKE designation
- Lead time for PMDA Formal Consultations shortened to 1 month (standard lead time for application is 2-3 months prior to consultation)
- Prioritized NDA review
- Ability to submit English materials for pre-review
- NDA Review period shortened to 6-months
- Ability to submit Phase 3 study results following NDA submission
- PMDA Review “Concierge”- Assignment of a PMDA manager to oversee the entire approval process, including issues related to conformity assurance, quality management, safety measures, review, etc
- Post-Marketing re-examination period extended up to 10 years
- Premium pricing increase of 10-20%
Conditions for SAKIGAKE designation
- The drug possesses a new and different mechanism of action from already approved drugs
- The drug treats either:
- A serious life-threatening disease
- A chronic disease which deteriorates patients’ QOL and for which there is currently no viable treatment
- The drug is expected to be more effective than currently approved treatments
- First approval targeted for Japan, and either (both preferable) of the following:
- First in Human (FIH) Study conducted in Japan
- Proof of Concept (POC) Study conducted in Japan