China FDA Tells Sponsors to Verify Trial GCP

Sponsors of new drug applications in China must submit comprehensive data showing adherence to clinical trial requirements by Aug. 25 — in a surprise move that could prompt noncompliant or unprepared companies to withdraw their applications, reducing a pending backlog of more than 1,600.

Under a directive issued on July 22, drugmakers must provide an electronic version of any inspection reports, along with scanned copies of trial contracts, information about the key research team and an authenticity document signed by a legal representative. The required data covers patient samples, test equipment, supply chain and adverse events.

The China Food and Drug Administration is giving manufacturers a warning to allow them to self-withdraw any applications that might not meet CFDA standards, says Helen Chen, head of L.E.K. Consulting’s China life sciences practice.

Chen doubts the CFDA has the resources to review all of pending submissions. This gives the agency justification for conducting surprise inspections if it suspects a sponsor is out of compliance or a submission is not up standards, she adds.

The short deadline assumes that trial sponsors already have the records on hand and merely need to organize them for submission, says Chen. Multinational drugmakers and contract research organizations shouldn’t have a problem complying, but domestic manufacturers could feel pinched to show that their trials are up to CFDA standards, she says. — Jonathon Shacat


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