The National Medical Products Administration (NMPA) (formerly the China Food and Drug Administration or CFDA) has released new guidelines on preparing clinical trial data generated overseas. In an effort to reduce repetitive clinical trials and to accelerate the process of medical device certification, data requirements are no longer limited to pre- or post-market clinical data. However, applicants must meet the guideline requirements.
The guideline includes three principles; ethical, regulation, and scientific.
The applicant should illustrate that the clinical trial in the selected country or region has followed applicable codes of ethics, laws and regulations formulated by regional or international norms and standards.
If the clinical trial conforms to clinical trial quality control standards, but differences exists with China’s Good Clinical Practice (GCP) guidelines, the differences should be specified.
Overseas clinical trial data should be authentic, scientific, reliable, and traceable. The applicant should provide the complete trial data, screening is not allowed.
Requirements for overseas clinical trial data
Overseas clinical trial data should include at least; a clinical trial protocol, ethical opinion, and a clinical trial report with complete analysis of the clinical trial data and conclusions.
Validation data can be used to prove that differences with an equivalent device does not impact the safety and effectiveness of the device.
Multicenter clinical trial data that was generated in China and should clearly define the number of patients enrolled in China.
Technical considerations for overseas clinical trial data
Technical evaluation of requirements
Overseas clinical trial data should be consistent with NMPA issued medical device technical guidelines. If there are inconsistencies with the guidelines, sufficient justification and evidence should be provided.
The following are examples of differences that you should take into consideration when submitting registration file to NMPA.
The following factors may influence patient enrollment in a clinical trial;
- Internal factors: human genetic characteristics or demographic characteristics, including race, ethnicity, age, or gender.
- External factors: social environment, natural environment, culture, including dietary habits, religious beliefs, the exposure environment, smoking, drinking, disease incidence, rare or regional comorbidities, obesity, treatment concept, social economic conditions, degree of education, or medical treatment compliance.
Differences in clinical trial conditions
Trial condition differences can include: medical environment, medical facilities, the researcher’s ability (learning curve), diagnosis and treatment , and philosophy or standards (for example, different ideas or standards in treatment, that may not conform to China’s clinical operation guide).
In addition, NMPA suggested that the applicant can fully communicate with the reviewer before submitting overseas clinical trial data, in order to reach mutual consensus for the clinical data’s scientific conclusions and application completion level.
Qserve China team can support to arrange the communication with NMPA reviewer. Please do not hesitate to contact us via email: firstname.lastname@example.org or by phone: +31 20 78 82 630.