In mid-June, the Chinese NMPA promulgated a new guideline on a trial basis to standardize inspections of device clinical trial sites. In the past, device clinical trial oversight has been somewhat lax, and these guidelines hope to improve the safety and quality of Chinese medical device clinical trial sites. The trial guideline is geared toward giving NMPA officials a more formal way to evaluate the operations of clinical trial institutions. The trial guidelines cover 18 inspection areas and close to 100 specific issues. Institutions doing device clinical trials must pass inspections and if problems are found they must be corrected. Failure flaws are outlined as serious, major, or general.
Failures are reported according to the number of problems at each site. Three evaluations are outlined in the guidance including – 1. Compliant – where there are not major issues, and the number of minor problems is less than five, 2. Requires Adjustment – includes up to three major issues and general flaws are higher than five, 3. Non-compliant – includes one serious problem, three major problems and/or any other deficiency that affects the trial or patient health. Detailed requirements cover topics like – 1. Institution’s file records, 2. The ethical review procedures, 3. The overall quality of the management of the institution and how well they train their staff, and 4. Concurrence with GCP institution regulations. These new guidelines will be adjusted over time according to the NMPA’s inspectors’ assessments.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.