On February 23, 2016, the China Food and Drug Administration (CFDA) published the draft of Interim Provisions on the Procedures for Drug Clinical Trial Data Verification (the Provisions), soliciting public comments by March 3, 2016.
The draft Provisions set forth procedures for on-site verifications of drug clinical trial data by CFDA. Under the draft Provisions,
- The on-site verification will be conducted by the CFDA’s Center for Food and Drug Verification (CFDI). CFDI is expected to establish a communication and coordination mechanism with CFDA’s Center for Drug Evaluation (CDE), under which CDE will provide CFDI with information on drugs for which on-site verification shall be conducted, and CFDI will develop a verification plan accordingly.
- 10 days prior to the on-site verification, CFDI will publish its verification plan online, notify the relevant drug registration applicant and the local Food and Drug Administration. The applicant may decide to withdraw its drug registration application within such 10-day period, and failure to withdraw within this time period will be deemed as consent to the on-site verification. Withdrawal of the application after this time period will not be permitted.
- CFDI will conduct on-site verification in accordance with the Key Points for On-Site Verifications of Clinical Trial Data published by the CFDA in November 2015. CFDI will conclude its determination within 10 days after the verification and will communicate its conclusion to the applicant and principal investigators.
- CDE will finalize its technical review of a particular drug after receiving the on-site verification conclusion from CFDI. In case the on-site verification reveals any false or incomplete clinical data that could affect the evaluation of the safety and efficacy of the drug, CDE will make its decision within five days and submit it to CFDA for final decision.
CFDA currently has an on-going enforcement program against clinical trial data of all pending drug registration applications. The program started with self-assessment and self-reporting by companies, followed by on-site verifications by CFDI. False or incomplete clinical data have been revealed in this process, which may lead to CFDA’s rejection of the relevant applications.
Going forward, pre-approval verification of clinical data may become a routine CFDA requirement. Verification procedures, especially coordination between CDE and CFDI, and appeal and feedback mechanisms for companies, will be critical. Companies are therefore advised to carefully review the draft Provisions and provide comments on these critical issues.