Overseas Clinical Data

The purpose of submitting overseas clinical trial data is to convince the NMPA reviewer that the clinical data obtained from previous overseas clinical trials is also valid under China’s regulatory environment, and the previous clinical results and conclusions are also applicable for Chinese patients.

China Med Device’s experienced contract research organization (CRO) team can provide overseas CD submission service consists of three phases including:

Phase I – Feasibility Evaluation

In the Phase I evaluation, CMD will review all existing materials and evaluate if its clinical data from overseas meets the three fundamental principles and rules set by NMPA.

Phase II – Differences Analysis and Justification

In the Phase 2 stage, CMD will help you to analyze the three major differences and justify that the trial data and conclusion is also applicable for Chinese patients.

Phase III – Submission and Follow-up

CMD will submit the overseas clinical trial data and analysis report to NMPA with the registration dossier. CMD will assist you to address questions raised by the NMPA reviewer during the supplementary phase.

An Overview of 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.

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.

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

The Key Guidance Documents Related to Overseas CT Data:

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

The Rationale that needs 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

Trends for Overseas Clinical 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.

Other Facts

1. Overseas CT data can be used on Clinical Trial Approval (CTA) products.
2. ISO14155 is acceptable.
3. Only CT data and supplemental data is acceptable under these guidelines. Not clinical experience/use data, RWD, or literature data.
4. Multi‐regional clinical investigation (MRCI) data (with China sites) is acceptable，and there are no specific requirements on Chinese sample size.
5. Hong Kong data is in the scope of this guidance, depending on the GCP/clinical practice differences.

Find more information about current China NMPA Clinical Pathways for Medical Device Registration in this white paper: Current China NMPA Clinical Pathways for Medical Device Registration.