Recently，There are media publishing & ldquo; Reporting clinical data authenticity My stake betting appin the application of new drugs。

 

  This，The person in charge of the Pharmaceutical Registration Department of the General Administration of Food and Drug Administration responded to the response，& ldquo; 80 % of the clinical data of new drugs involved & rdquo;，Can't simply withdraw the company withdrawn into data fraud。As of the end of September this year，There are 30 pharmaceutical registration applications due to suspected clinical data authenticity.。

 

  The person in charge of the Pharmaceutical Registration Department of Food and Drug Administration introduced，July 22, 2015，Food and Drug Administration issued the "Announcement on the Checking of Self -examination of Drug Clinical Test Data"，Requires the applicant to the authenticity of the clinical trial data of 1622 registration applications for listing and imports、Integration、Self -checking，Disposter 193 of clinical trials，There are 1429 varieties that need to be self -examination。The applicant's registration application for clinical trials can take the initiative to withdraw，Supplement and complete re -declaration Stake Sports Bettingafter perfecting。As of the end of June 2016，The company took the initiative to apply for the withdrawal of 1193，accounts for 83%of the total self -examination total。

 

  From October 2015，Food and Drug Administration of the General Administration of Food and Drug Administration for the registration application for approval to conduct verification。As of the end of September 2016，Check a total of 117 registration applications，Thirty decisions of 30 authentic problems，About 2%of the species of self -examination and check。

 

  The person in charge of the Pharmaceutical Registration Department of Food and Drug Administration emphasized，There are many reasons for the active withdrawal of corporate self -inspection，Some do not meet the quality management specifications of clinical trials，The scientific and accuracy of the results of the test results; some are incomplete data，cannot be traceable，Not enough to prove the safety and effectiveness of the application of drugs; some data are not real，Do not rule out intentional fraud。

 

  Person in charge of the Drug Scouting Department of the General Administration of Food and Drug Administration pointed out，Drug research must be scientific、Rigidity，No fake，Can't deliberately stake sports betting appfalsify。Carry out clinical data self -examination inspection，False Data False，is to encourage innovation，Create a good environment for fair competition，Make sure that the drug is effective and effective for the drug is approved。Self -examination and verification of the entire drug clinical data is transparent and open。Since July 22 last year，Our Bureau has issued 21 announcements，Discover the progress of work to the society。