Final Guideline for IVD Overseas Clinical Data Acceptance: Six Types of Differences to Pay Attention

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NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostics” on December 3, 2021, finalizing the draft version issued in late November 2020.

Clinical data generated outside of China can be used toward registration if it meets the guidance requirements. The purpose of submitting overseas clinical data is to convince the NMPA reviewer that the clinical data obtained from overseas is also valid under China’s regulatory environment, and the previous clinical results and conclusions are also applicable for Chinese patients. Overseas data acceptance is one of clinical pathways and can be used as a local Chinese clinical trial alternative in NMPA device registrations.

China Med Device’s experienced contract research organization (CRO) team can provide overseas CD submission service consists of Feasibility Evaluation, Differences Analysis and Justification and Submission and Follow-up. For our service page on overseas clinical data acceptance, please click HERE

Differences between Domestic and Overseas Clinical Trials

The differences between domestic and overseas clinical trials should be analyzed first, the guideline says. It lists the six 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. Other differences

For each difference, it gives examples including:

  • HER-2 antibody reagent
  • PD-L1 antibody reagent
  • Microbial susceptibility reagent
  • Gene polymorphism reagent
  • Human papillomavirus (HPV) nucleic acid screening reagent
  • Hepatitis B virus (HBV) genotyping reagent
  • Reagents for detection of drug resistance gene mutations of Mycobacterium tuberculosis

The 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.

Acceptance Qualification

The guideline gives detailed requirements for IVD overseas clinical data acceptance:

  • 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

For post on overseas clinical trial acceptance for general medical device, please click HERE.

To get an English copy of the IVD Overseas Clinical Data Acceptance guideline, please email info@ChinaMedDevice.com. We charge nominal fees to the translation.

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