Japan’s Regulatory System to Undergo Needed Overhaul . . . in Time

June 22, 2012 – 8:13 am

The Japanese government will consider revising the Pharmaceutical Affairs Law (PAL) and treat medical devices separately, according to a new national strategy drawn up earlier this month by the government council.

The move is strongly welcomed by industry, which has long cast the PAL as an obstacle to the development of innovative medical devices. Currently in Japan, medical devices and drugs share the same regulatory bucket. The government’s announcement came in response to a petition filed in July 2011 by the Japan Federation of Medical Device Associations (JFMDA) requesting regulations that specifically target the medical device industry.

“Creating device-focused chapters [in the regulation], and adopting a fast-track approval system for previously approved devices that have received upgrades are our two biggest wishes,” says Ryutaro Iida, who wrote the petition last year on behalf of JFMDA. “The government actually specifying these items in its basic strategy is a great step forward,” says Iida.

Industry eagerly awaits progress on this measure, as the revision would accelerate the approval process, but getting there will require some patience.

The bill will be submitted to the National Diet, the country’s legislative body, next year at the earliest, according to Iida. “That means that it will take at least another couple of years for the revised law to come into force.”

Iida says that JFMDA is finding more-immediate ways to improve business prospects for industry.

In concert with the American Medical Devices and Diagnostics Manufacturer’s Association and the European Chamber of Commerce in Japan, JFMDA is currently negotiating with the health ministry to expand the range of medical device items that require no approvals for partial changes, and to loosen some rules for foreign medical device manufacturers.

The Japanese government created a strategic council in 2010 to promote medical innovation, a key policy goal under the country’s growth strategy. Some JFMDA members sit on the council, ensuring that the association’s requests are properly reflected in the government’s policy decisions.

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