Amended Chinese GCP could aid development of CRO industry

20-Feb-2015 - Last updated on 20-Feb-2015 at 08:27 GMT

China is looking to amend its GCP and bring more of the clinical trial industry up to speed

The China Food and Drug Administration (CFDA) is proposing to amend its GCP (good clinical practices) to add more specific responsibilities for sponsors, Ethics Committees (ECs) and sites as part of efforts to further protect study subjects, experts say.

The release of the new draft guideline includes new details on interactions between sponsors and CROs (contract research organizations) and may help boost the local CRO industry.

Under the revised GCP, sponsors are permitted to outsource certain tasks in clinical studies to CROs as long as CROs’ responsibilities are clearly documented in contracts, Katherine Wang, a leading life sciences regulatory lawyer in China and partner at Ropes & Gray, wrote recently. Responsibility and liability for clinical trials were often outsourced as well, prior to the release of these latest standards.

Sponsors are also required to evaluate and inspect CROs and, like in the US, are ultimately responsible for the quality of the work performed.

Wang told Outsourcing-Pharma.com that the amended GCP “clarified that sponsors are allowed to outsource various tasks to CROs, but they cannot outsource the regulatory responsibilities.”

“This clarification will aid a healthier development of the CRO industry,” Wang told us. “The amended GCP does not introduce any new regulatory scrutiny over CROs, but given that the responsibilities of sponsors have been strengthened, it may be more costly to run studies in China.”

Other Provisions

The proposed GCP, which is the first revision since 2003, also call on local FDAs to be more involved in day-to-day supervision of clinical studies.

“Concerning the administration of study drugs, the revised GCP requires sponsors of BA/BE studies to retain sufficient samples from the same batch of study drugs for at least two years after receiving marketing authorizations,” Wang wrote. The proposed GCP also clarifies that sponsors are responsible for continuously evaluating the risks and benefits of study drugs, as well as analyzing any safety-related information they receive, and promptly reporting any unexpected serious adverse events to governmental authorities.

New requirements for ECs include the need for them to be independent and disclose their charters and procedures to the public. ECs also must review and approve clinical trial protocols and all written documents to be provided to subjects, as well as any serious adverse event, or any other event or new information that may change the risk/benefit analysis of a potential drug. And at least once a year, ECs must conduct periodic evaluation of the subjects’ risks and benefits.

“The China FDA has been in the process of amending the GCP for a few years. Overall, the amended GCP is believed to create positive impact on the industry,” Wang told us. Comments on the draft guidance are due Feb. 28.