In July 2020, the new version of China GCP became effective after going through four-year long edit. The background for the revision, as stated by National Medical Products Administration (NMPA), was to keep pace with the use of technology and innovative approaches, to address the frequent issues identified during inspections, and to be in-line with relevant ICH guidance.
While the structure and content of new China GCP are highly consistent with ICH E6 (R2), there are unique aspects to fit for the regulatory infrastructure setting in China. How research institutes and IRBs respond and implement the regulatory requirements will impact sponsor/contract research organization (CRO) operation strategy. Therefore, sponsors and CROs need to understand the key differences within the new GCP framework to ensure universal compliance
Additionally, the Center for Food and Drug Inspection (CFDI) of NMPA has revised the pre-approval GCP inspection checklist to incorporate the new regulatory requirements. In 2019, a paper published by CFDI summarized inspection findings related to sponsor responsibilities revealed trends within China’s inspection focus. This course will help you understand the key updates to GCP within China, points of harmonization with ICH, and strategies to keep your efforts compliant.
At the completion of this session, you will be able to:
- Summarize the key updates in the China GCP 2020 revision
- Recognize the latest implementation strategies and trends within research institutes and IRBs to adhere to the new regulation
- Describe the key focus areas of the China CFDI pre-approval GCP inspection
- Outline the regulatory expectations of NMPA in terms of GCP compliance