China's FDA has issued a deadline for all drugmakers to submit signed internally audited data for clinical trial applications by late August, as it warns the information could prompt unannounced inspections and the prospect of having to withdraw filings if discrepancies to submissions already made pop up.
The deadline of Aug. 25 outlined in a CFDA release last week says applicants must submit an electronic version of the inspection report to the State Food and Drug Administration Food and Drug audit identification centers, along with a scanned copy of the clinical trials contract, names of the research team members and other key personnel as well as notarized signatures.
In a July 28 blog post, Law firm Sidley Austin said the new rule had "far-reaching" implications for "the 1,622 pending drug registration applications that cover imported and local drugs" and has caught firms by surprise.
Sidley Austin noted the CFDA also requires a locked database consistent with the original data as well as related statistical analysis and summary reports, among other comparisons across maintenance of biological sample analysis and data records.
"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," the Sidley Austin blog said.
"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."
Multinational drugmakers in particular are also eyeing the announcement for any implications for approval delays and for the use of multiregional clinical trials in applications.
In a hopeful sign for companies that use the MCRT pathway, CFDA has joined the International Coalition of Medicines Regulatory Authorities as part of efforts to harmonize its regulation efforts as companies seek to increase the number of Chinese patients in global trials.
Also in July, in a separate notice, CFDA also announced it would conduct surprise inspections of drug manufacturing sites starting in September by inspectors who will digitally record the investigations.
|CFDA Commissioner Bi Jingquan
CFDA Commissioner Bi Jingquan last month called for improved drug quality aimed at quality at a large industry gathering, kicking off expectations by firms across the country of more changes ahead as he specifically noted that "we encourage makers to file generics applications based on bioequivalence (BE) testing that is equal to originator drugs," according to local press reports.