China Food and Drug Administration Announces Penalties for Clinical Trial Data Integrity Violations

On May 24, 2017, the China Food and Drug Administration (CFDA) issued its [2017] Circular No. 63 (the Circular), setting out penalties for clinical trial data integrity violations, including intentional data falsification, incomplete and incompliant data and other data defects. The highlights are:

1. Legal responsibilities of different participants in a clinical trial are clarified as follows:

  • Drug registration applicants, being sponsors of clinical trials, shall ensure the truthfulness, completeness and compliance of clinical trial data included in the application dossier, supervise the performance of the clinical trial, and be legally responsible for the reliability of the application dossier and clinical trial data included therein.
  • Investigators, under the supervision and management of the clinical trial sites, shall conduct clinical trials in accordance with Good Clinical Practice and shall ensure and be directly responsible for the truthfulness, completeness and compliance of clinical trial data.

2. The following incidents will be considered intentional data falsification:

  • Fabricating or modifying, without reasonable justification, information on trial subjects, trial data, trial records, or investigational products.
  • Utilizing fake investigational products, such as switching investigational products with reference products, or replacing self-developed investigational products with commercial products.
  • Concealing trial data, discarding trial data without reasonable justification, or otherwise selectively using trial data in violation of the trial protocol.
  • Concealing serious adverse events or serious adverse drug reactions associated with investigational products.
  • Concealing information on use of drug combinations prohibited by the trial protocol.
  • Intentionally destroying or concealing trial data or data storage medium.
  • Other circumstances where the data integrity is intentionally compromised.

3. In the event that intentional data falsification is found and substantiated by the CFDA during on-site inspections after November 11, 2015:

  • Drug registration applicants will have a three-year ban imposed on registering the relevant drug, and a one-year ban imposed on submitting any drug registration applications, except for those with urgent medical demand. Legal representatives and responsible personnel whose signatures are on the applicant dossier may be penalized personally.
  • Clinical trial sites found with data falsification will be required to rectify the data within a prescribed period. During this period, the relevant department may not conduct new trials or enroll patients for any ongoing trials, and the CFDA will not accept any drug registration applications with data from that department. More clinical trials from the same site will be similarly affected if more data falsification incidents are found.
  • Drug registration applicants affected by the above penalties on clinical trial sites may voluntarily withdraw their applications from the CFDA with no further penalties or request another on-site inspection by the CFDA on their data generated from these sites.

4. The CFDA will reject drug registration applications if they contain incomplete and incompliant data that is not sufficient to prove the safety and efficacy of the underlying drug. To the extent the clinical trial data is incompliant but can be corrected and improved with additional information, the applicant will be given one opportunity to supplement the data for the CFDA’s continuous review.

5. Procedurally, the party to receive any of the above penalties may submit its written defense within three days before the CFDA makes its final decision, and the CFDA’s final decision is subject to administrative review and/or administrative litigation. In case of administrative review, the CFDA will organize a hearing with the claimant and consult with its expert advisory committee to the extent necessary.