Asia Regulatory Roundup: China Rolls out New Clinical Practice Rules (24 February 2015)
China Food and Drug Administration’s (CFDA) recently introduced draft good clinical practices (GCPs) will clarify the process for outsourcing to contract research organizations (CROs), Outsourcing-Pharma reports. Katherine Wang, a partner at legal firm Ropes & Gray, told the publication the draft GCPs tell sponsors to state what responsibilities are being taken on by a CRO in their contracts with the vendor. The US Food and Drug Administration (FDA) takes a similar approach, with the regulator viewing sponsors as responsible for all tasks except those specifically named in writing as being transferred to the CRO. CFDA has also followed FDA’s lead with regard to who is ultimately responsible for the quality and integrity of the work. The Chinese draft GCPs state regulatory responsibilities cannot be outsourced, meaning the onus is on sponsors to ensure their CROs are complying with CFDA standards. Overall, Wang expects the changes to have a positive effect.