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在线翻译:
szdaily -> Business
Govt. to speed up drug approvals
    2017-October-10  08:53    Shenzhen Daily

THE government is looking to speed up approvals for new drugs and plans to accept data from clinical trials carried out overseas, a potential boon for international drugmakers and patients who faced lengthy delays for new medicines to reach the market.

The move, announced by the State Council late Sunday, said foreign drug trial data would be accepted in a bid to accelerate approvals and help China close an innovation gap with developed international markets.

“Clinical trial data from overseas centers that complies with Chinese drug and medical device registration requirements can be used to make registration applications in China,” the draft proposals posted on the State Council’s website said.

The move should help speed up approvals in the world’s second-largest drug market, after the United States, where global firms have faced rising challenges from Chinese rivals.

The proposal said that firms looking to register drugs or medical devices for the first time would need to provide clinical trial data related to any racial divergence relevant to the Chinese market.(SD-Agencies)

 

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