China Global Regulatory Program
Focus Area: Global Regulatory Engagement
In November 2014, the China Food and Drug Administration (CFDA) issued a Draft Guidance on Multi-Regional Clinical Trials (Provisional) to set forth requirements for clinical trials in China. The guidance outlined CFDA’s then current interpretation of existing regulatory requirements.
Beginning in early 2015, the MRCT Center, in collaboration with Peking University developed scientific principles upon which to ground decision-making for MRCTs. A focused effort on training has continued to drive current efforts in China.
Current status: Implementation and Dissemination
Impact: Provide scientific approach, based on statistical analyses, for the utilization of results from an MRCT to demonstrate safety and efficacy in a particular study.
- Determine if the sample size of a particular population in the total study population is sufficient to evaluate and demonstrate safety and efficacy for patients in that country
- Determine how scientific and statistical justifications align with existing legal requirements for MRCTs
- Develop methods for analyzing the consistency of regional sub-groups and the overall study data (trend analysis) for key safety and efficacy outcomes
- Develop guidelines (or an algorithm) of how external and internal factors in different regions may impact drug efficacy and/or safety
- Provide a framework based on ICH E5 and ICH E-17 General principles on planning/designing Multi-Regional Clinical Trials for how countries can consider the importance of ethnic factors in the evaluation on drug efficacy/safety for the design of MRCTs.
Key project Milestones:
- March 2015: Launched project with Peking University
- April 2015: First roundtable teleconference
- June 2015:
◦ Roundtable in Shanghai
◦ Launched Consistency and Region Working Group
- October 2015: Workshop in Beijing
- May 2016: Global Simultaneous Drug Development Workshop in Beijing
- September 2016: China FDA Training at Yale University
- March 2017: Patient-Centric Clinical Trials Conference in Shanghai
Related external links:
“China to Reform Review and Approval Process for Drugs and Medical Devices” — A blog by the Harvard Law Petrie-Flom Center and friends
Program Lead: Rebecca Li, Mark Barnes, Barbara Bierer