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39 Pharmaceutical Products to be Checked on Site, Foreign Pharmaceutical Enterprises Having Defects en-cphi.cn
May 05, 2017
Center for Food and Drug Inspection of CFDA issued the Announcement on On-site Checking Plan for Drug Clinical Trial Data No. 11 on April 28.
Which Pharmaceutical Products Have Entered Priority Review? What are the Conditions Required to Ente en-cphi.cn
April 28, 2017
Under the circumstances of a huge number of applied varieties and limited review resources, obtaining the right for priority review of enterprises’ pharmaceutical product applications can certainly largely reduce...
China FDA Accepts JHL's First Clinical Trial Application contractpharma
April 11, 2017
JHL1101 is a biosimilar that JHL is pursuing as part of its strategic biologics alliance with Sanofi
Analysis of the Policy Signals in the 2016 Drug Review Annual Report of CDE en-cphi.cn
March 31, 2017
CDE (Center for Drug Evaluation, CFDA) issued 2016 Drug Review Annual Report on March 17, 2017.
China proposes new FDA rules to speed up foreign drug approvals fiercepharma
March 23, 2017
China's FDA published (Chinese) a slate of suggested amendments to its foreign drug registration rules Friday, which could dramatically revamp the country’s pharmaceutical market landscape by eliminating hurdles that slow approvals of Western drugs.
CFDA Chemical Drug Process Change Issue in the New Regulation Arousing Heated Discussion en-cphi
January 19, 2017
It gradually approaches the Chinese New Year holidays, but CFDA has never stopped its pace of intending to rectify the industry and continuing to introduce new policies.

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