Home> Laws and Regulations

NMPA Issued the Announcement on Registration Application Situation and Self-Examination & Verification of Drug Clinical Trial Data

CCFDIE| Updated: 2019-10-15

On October 15, 2019, NMPA released theAnnouncement on Registration Application Situation and Self-Examination & Verification of Drug Clinical Trial Data with decision made to verify the clinical trial data of 7 newly received registration applications for drugs that have completed the clinical trials and are applying for production, the relevant issues are hereby announced: 

I. If the drug registration applicants found inauthenticity of clinical trial data by self-examination before NMPA verification, they shall take the initiative to apply for withdrawal of registration application, NMPA shall announce the list of applicants and varieties withdrawn without affixing accountability. 

II. NMPA Center for Food and Drug Inspection shall publicize on its website and inform the applicants of drug registration and the competent local provincial drug regulatory authority of the on-site verification plan. The Center shall, 10 working days after the public notification, inform the date for on-site verification and no longer accept the applicants' withdrawal of drug registration applications. 

III. Pursuant to the law, NMPA shall severely punish the applicants, responsible persons and managers of drug clinical trials and responsible persons of CROs found with data frauds in drug clinical trial data on-site verification. 

Annex: List of Registration Applications for 7 Drugs with Self-Examination & Verification of Clinical Trial Data (Omitted)