On July 22, 2015, the China Food and Drug Administration (CFDA) issued a far-reaching Circular mandating applicants for a total of 1,622 pending drug registration applications, covering both imported and local drugs, to conduct self-inspection and verification on their clinical trial data. The purpose is to ensure authenticity and reliability of the data, as well as proper record-keeping.
Specifically, companies’ self-inspection must focus on the following areas:
- Whether the locked database is consistent with the original data, whether the data used in statistical analyses and summary reports are consistent with the original records and database, and whether there are changes in data, and the explanations for such change;
- Operation and maintenance of biological sample analysis and testing instruments (such as HPLC, LC-MS/MS), and installment and operation of the audit trail module of data management software;
- Screening, inclusion and exclusion of subjects in clinical trial institutions, compliance with the inclusion and exclusion criteria and review of subjects participation criteria;
- Data with respect to the number of clinical trial protocol deviations and exclusions, serious adverse events, information in the hospital HIS system on the study subjects with regards to patient visits, and lab testing;
- Records on manufacturing or purchase, testing, transportation, retention, return and destruction of investigational products and comparator products, together with relevant invoices, records and samples;
- Records on procedures for collecting, delivering and receiving, and storing biological samples, and validation of biological sample analytical methods; and
- Review of clinical trial protocol compliance by all parties.
Companies are required to submit their self-inspection report to CFDA by August 25, 2015, together with copies of clinical trial agreements, introduction of key investigators and other supporting documents. Companies may also voluntarily withdraw their registration applications from CFDA by the same deadline in case they have identified any inauthentic, incomplete or other non-compliant trial data through self-inspection.
CFDA will conduct further verification, including on-site inspections without notice, based on the self-inspection reports and may impose penalties on manufacturers, clinical trial institutions and clinical research organizations in case false, inauthentic or incomplete data are found. In particular, companies that have submitted such data may be banned from filing any drug registration applications with CFDA for a period of three years.