On August 2, 2008, the state administration of food and drug administration issued a notice on the application of data on clinical trials of drugs on the registration of clinical trials (no. 91, 2017). 

 

The state administration has decided to conduct clinical trial data verification on 61 new drug registration applications that have completed clinical trials to declare production or import, the statement said. 

 

By convention, administration of said first: drug registration applicant inspection found drug clinical trial data authenticity problems, should take the initiative to withdraw the application for registration and administration of state food and drug supervision and administration announced its list, shall be investigated for their responsibility. 

 

After 10 working days, the center will notify the site of the verification date and no longer accept the application for withdrawal from the applicant. 

 

The cost of counterfeiting is serious. 

 

According to the announcement, the state food and drug supervision and administration bureau for drug clinical trial data found in the inspection data of the applicant for pharmaceutical clinical test shall be given heavier processing partners and managers, contract research organization partners, and failed to effectively takes office will be the responsibility of the food and drug regulatory inspectors. 

 

Attached: 61 drug clinical trial data self-check registration application list