Changes have occurred in the organisation and procedural activities of the China Food and Drug Administration (CFDA) and the Centre for Drug Evaluation (CDE). Initiatives that were designed to improve the transparency of interactions between the CDE and external stakeholders appear to have slowed and potential challenges to drug registration have emerged. Previously acceptable procedures appear to be changing or implemented in new ways, potentially confusing and adding delays to the regulatory process. Importantly, moves to improve this environment are underway.
The purposes of this briefing are to assess recent CFDA decisions for the use of clinical data from multiregional clinical trials in China to support imported drug registration applications, describe the challenges that these changes pose through specific case studies and identify opportunities for timely medicines availability based on the experiences of other regulatory agencies that have faced similar challenges.