RDBriefing56-CIRS-TheCentreforInnovationin.PDF

UNDERSTANDING THE DYNAMICS OF CHINA’S MEDICINE REGULATORY ENVIRONMENT Key milestones of the Chinese regulatory process before and after 2002 Before 2002 CPP Drug Lag 6 years Clinical Phase I Phase II Phase III Approval IDL CTA IDL NDA Trial Since 2002 CPP Drug Lag ~ 2 years MRCT CTA Clinical Trial IDL CTA + NDA IDL CTA Submission IDL NDA Approval IDL NDA Submission Waive IDL CTA Approval Adapted from Scheeren J. 2014 International Multi-Center Clinical Trial Challenges. Presented at MRCT and GCP Inspection Workshop, Qingdao, China. Changes have occurred in the organisation and Contents procedural activities of the China Food and Drug Key points 2 Administration (CFDA) and the Centre for Drug Evaluation (CDE). Initiatives that were designed Background 3 to improve the transparency of interactions between the CDE and external stakeholders Survey insights appear to have slowed and potential challenges IDL-CTA/IDL-NDA process 5 to drug registration have emerged. Previously Case study 1: IDL-CTA/NDA process