Overseas clinical trial data for IVD registration in China now adopts the new technical guidelines issued (No.95-2021) on December 1, 2021, by the National Medical Products Administration (NMPA).
Based on the specific characteristics of the product, the applicant is required to submit a report that includes a comprehensive analysis of the differences between domestic and foreign clinical trials and its cause and effect to the domestic and foreign clinical trial data, in order to determine whether existing overseas clinical trial data is sufficient for registration approval in China.
The guideline lists out the common differences between domestic and foreign clinical trials:
- Differences in the clinical trial design key elements
- Differences in the comparison methods
- Differences in the sample size
- Differences in the subject population
- Differences in the genetic information of different ethnic groups
- Differences in the characteristics of diseases
- Differences with the technical guidelines
Different statistical analysis used in domestic and foreign clinical trials could also be a factor leading to differences in the clinical trial data. When using overseas clinical trial data as clinical evidence for the application of NMPA registration, the applicant should evaluate it‘s eligibility and scientificity to explain why supplementary clinical trials will not be required in China.
For more information on the clinical trial data submission requirements for medical device and IVD registrations in China, feel free to read our blog post on the technical review guidelines issued in November 2021, or contact Cisema to learn more.
By Alice Liu and Jacky Li.