The circular issued by the CFDA calls on the applicants of 1,622 pending drug registration applications, for both imported and local drugs, to conduct the self-inspection and verifications, according to the law firm Sidley Austin.
The circular also calls on the companies to focus on whether the country’s 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 if so, why those changes were made.
Companies are required to submit their self-inspection reports, clinical trial agreements, data on key investigators and other documents to the CFDA by August 25, though they may withdraw their applications if they’ve identified inauthentic, incomplete or other non-compliant trial data.
CFDA says it will conduct further verification, including on-site inspections without notice, based on the reports. The agency also may impose penalties on manufacturers, clinical trial institutions and CROs (clinical research organizations) in case false, inauthentic or incomplete data are found, in which cases companies may be banned from filing drug registration applications with for up to three years.
The self-inspections are also supposed to focus on the operation and maintenance of biological sample analysis and testing instruments (such as HPLC, LC-MS/MS), as well as the installment and operation of the audit trail module of data management software. According to the law firm, other major issues to address include:
- Screening, inclusion and exclusion criteria, compliance with that criteria and the review of participation criteria;
- Data on the number of protocol deviations and exclusions, serious adverse events, information 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, as well as 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.