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Q&A – Overseas Clinical Data

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What is overseas clinical data?

Based on guidelines for the acceptance of overseas clinical trial data for medical devices offered by the NMPA implemented on 11 January 2018, guidance stated that overseas clinical trial data is defined as research data generated during the process of confirming the safety and effectiveness of medical devices to be registered in China under normal conditions of use in all or concurrently overseas clinical trial institutions that meet the requirements of the country (region) where clinical trials are carried out.

In other words, data generated outside of China can be used toward registration if it meets the guidance requirements. Overseas data acceptance is one of clinical pathways and can be used as a local Chinese clinical trial alternative in NMPA device registrations.

What are the key requirements from the NMPA (CFDA)?

1. IVD included in scope.
2. Require gap analysis when GCP gap exists.
3. The data must be from clinical trials.
4. Clear requirements on the data and acceptance criteria.
5. Considerations on overseas data acceptance, including technical review difference, population difference, and clinical condition difference.
6. Internal and external factors should be evaluated on population difference.

What are the highlights of the NMPA acceptance guidelines?

Four THREEs:

1. 3 Principles: ethical, legal, and scientific
2. 3 Considerations: technical review, population, and clinical condition
3. 3 Scopes: overseas CT only, MRCI with China sites, both pre‐ and post‐market studies
4. 3 Usages: clinical trial pathway, supplement for local trial, clinical data in CER

What are the key guidance documents related to overseas clinical trial numbers?

1. Technical Guidelines for the Acceptance of Overseas Clinical Trial Data of Medical Devices. NMPA 2018.1
2. Technical Guidelines for Overseas CD Acceptance on In Vitro Diagnostic (Draft). NMPA 2020.11
3. Technical Guidelines for Clinical Evaluation Reports for Medical Device Registration and Application (Draft for Comments) NMPA 2021.5
4. Technical Guidelines for Clinical Evaluation of Medical Devices (Draft for Comments) NMPA 2021.5

What rationale need to be provided and justified for pathway acceptance?

Rationale and justification are acceptable for:

1. GCP differences
2. Inconsistence with local product specific requirements
3. Communication with CMDE prior to submission is encouraged

What are trends for data pathway based on successful cases approval by NMPA?

1. Clinical trial Pathway: cases leveraging overseas CT data only are still limited.
2. CER Pathway: overseas data are acceptable before the guidance in 2018, thus leveraging overseas data in CER was well developed and widely used.
3. MRCI or overseas clinical trial + Local Bridging Study Data: cases are still limited.
4. Overseas CD + Local RWD (e.g., Hainan Boao RWS Initiative): may be new opportunities.

Overseas CT data can be used on Clinical Trial Approval (CTA) products?

Yes.

Is ISO14155 acceptable?

Yes.

Are clinical experience/use data, RWD, or literature data acceptable under this guideline?

Only CT data. These data can be supplemental data.

Are multi‐regional clinical investigation (MRCI) data (with China sites) acceptable, and any requirements on Chinese sample size?

Yes, MRCI data are acceptable, no specific requirement on sample size allocation for Chinese.

Are Hong Kong data in the scope of this guidance?

Depends on GCP/clinical practice differences.overseas clinical data