Japan’s Regulatory Agency Goes Back to School

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has entered into a collaboration with Gifu University to promote education and research involving medical technology. Under the agreement, students at Gifu University’s United Graduate School of Drug Discovery and Medical Information Sciences can attend classes taught by PMDA staff and have an opportunity to spend time working at PMDA headquarters and getting an in vivo view of the medical device review process.

The move is part of PMDA’s efforts to expedite the review process for drugs and medical devices by strengthening regulatory science and cultivating professionals who can evaluate the safety and efficacy of products more quickly.

“In the medical device field, this is our first . . . collaborative agreement with a local university,” says PMDA Chief Executive Tatsuya Kondo. PMDA previously collaborated with seven local universities in pharmaceutical activities. “Through these co-operations, we hope to provide the driving force for the development of new drugs and medical devices,” Kondo adds.

Gifu University has been active in tackling development of advanced medical devices in partnership with industry, government and academia. The school established an R&D Centre for Human Medical Engineering in 2010, focusing on developing next-generation technologies such as medical robotics.

“Stimulating research and development of medical technology is a national project, and we would like to [introduce] the nation’s best and brightest to the medtech industry,” says Gifu University President Hideki Mori.

Japan’s medtech industry has long been characterised by a rigid regulatory system and the infamous “lag time” that hinders access to medical technology. Of late, the government seems to be more receptive to streamlining the product approval process and encouraging innovation. As noted in a recent blog post on medtechinsider, a strategic council was established in January 2011 to promote medical innovation, a key policy goal under the nation’s new growth strategy. The government is also making efforts to improve the regulatory system to encourage exports and secure a more stable supply of medical devices.

Tags: device lag, Gifu University, Japan device regulation, PMDA