Draft Guideline for Overseas Clinical Data Acceptance on IVD: Nine Types of Differences to Pay Attention

NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostic (IVD) (draft)” for comments on November 25, 2020. Feedback needs to be submitted by December 15, 2020.

Differences between Domestic and Overseas Clinical Trials

The differences between domestic and overseas clinical trials should be analyzed first, the draft guideline says. It lists the nine types of differences as follows:

1. Difference in clinical trial quality management system
2. Differences in clinical trial institution and personnel
3. Differences in comparison method or comparison assay
4. Difference in genetic information among different populations
5. Difference in disease characters
6. … …

The draft guideline also specifies that if the overseas clinical trial data cannot fully support the intended use in China or cannot fully meet the relevant requirements for the registration of clinical trials in China, the overseas clinical trial data can be taken as part of the clinical evidence for the registration in China. The applicant should supplement the clinical trial within or outside China as appropriate.

For post on overseas clinical trial acceptance for general medical device, please contact us.

Documents Requirements

To qualify for the overseas clinical data acceptance, the draft guideline gives detailed requirements as follows:

• If the clinical trial data is complete and if Chinese population data is included
• If the ethical opinions, clinical trial protocols and clinical trial reports are complete, authenticated, reliable and traceable
• If the differences between domestic and overseas clinical trials are dresses

It is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical guideline in the end. A thorough and realistic guidance document not only helps NMPA reviewers during their technical review process but also guides manufacturers to satisfy NMPA’s requirements. For more information about how to develop a feedback strategy or assistance in submitting your inputs, please contact info@inspirativemed.com.