Asia – Asia-Pacific Roundup

PMDA sets out plan for accelerating medical devices access

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published details on how it plans to accelerate the approval process for advanced medical devices that address unmet medical needs.

PMDA has already shortened medical device review times. In fiscal 2019, PMDA typically took 11.1 months to review normal devices and 7.3 months for priority candidates, beating its respective targets of 14 months and 10 months. PMDA chief executive Fujiwara Yasuhiro said the data show “the device lag that had previously been a problem in Japan” is now a thing of the past.

PMDA now is trying to accelerate access to specific groups of products. Yasuhiro highlighted four specific initiatives.

A breakthrough device program, called Sakigake, provides priority access to PMDA, enhanced pre-submission consultation, and accelerated review to devices that impress in early-phase clinical trials. PMDA has set a six-month target review timeframe for Sakigake devices…