China to accept overseas trial data in bid to speed up drug approvals

SHANGHAI (Reuters) - China said it plans to accept data from overseas clinical trials to speed up approvals of drugs, a potential boon for international drugmakers as well as patients who often face lengthy delays for new medicines to reach the market.

The move, outlined by the Cabinet late on Sunday, seeks to address high medicine costs and access to healthcare for China’s population of nearly 1.4 billion. In the past five years, China has approved just over 100 innovative new drugs, about one-third the number in developed markets.

Accepting overseas clinical data will help global drugmakers at time of growing competition from Chinese rivals in the world’s second-biggest pharmaceuticals market as well as pressure from authorities which are anxious to rein in prices.

 “Overall, China’s support for scientific innovation with drugs and medical devices is lacking, and the quality of products on the market still falls short of top international levels,” the draft proposals said.

“We must speed up the examination and approval of urgently needed drugs and medical devices.”

The Cabinet also said it would look to improve the protection of medical intellectual property and boost the number and quality of clinical trial testing centers in China. The proposals contained no timeline for implementation.

“We want to make our drug industry large-scale and strong, make it more competitive, and shift our long-term reliance on imports of new drugs,” Wu Zhen, deputy head of the China Food and Drug Administration, told a briefing on Monday.

“(Some drugs) have been used overseas for 6-7 years before making it to market in China,” Wu added.

China in March proposed ways to speed up approvals for imported drugs, including reforming clinical trial requirements. It also wants to boost its own drug industry and see a shift from generic drugs and towards more innovative medicines and medical equipment.

Reporting by Adam Jourdan; Editing by Richard Borsuk and Edwina Gibbs

October 9, 2017

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