Using Overseas Clinical Trial Data

1. The scope of applying overseas clinical trial data

According to the "Technical Guidelines for Using Overseas Clinical Trial Data of Medical Devices", when applying for medical devices (including IVD products) registration in China, applicants are accepted to use overseas clinical trial data as clinical evaluation data.

2. Submission and acceptance requirements of overseas clinical trial data

　a)The overseas clinical trial data submitted by the applicant should at least include: clinical trial protocol, ethical opinions, and clinical trial report. The clinical trial report should include the analysis and conclusions of the complete clinical trial data.

　b)According to the relevant technical requirements, supplementary clinical trials (i.e., small sample size clinical trials) can be carried out within or outside China, and the supplementary trial data and the original overseas trial data will be accepted if they meet the relevant technical requirements.

3. Considerations and technical requirements while accepting overseas clinical trial data

　a)Requirements and differences on technical review

　　i.Clinical trials conducted abroad may meet the technical review requirements of the country (region) where the trial is conducted, but may not fully meet the relevant review requirements of China. When there is such a difference, it is necessary to provide evidence that can prove that the safety and effectiveness of the medical device meets the standard.

　b)Differences among the subjects

　　i.Intrinsic factors: Refers to the influencing factors based on human genetics or demographic characteristics, including race, ethnicity, age, gender, etc.

　　ii.External factors: Refers to factors that are based on social environment, natural environment, and culture, including eating habits, religious beliefs, exposure environment, smoking, drinking, disease incidence, rare or regional comorbidities, obesity, treatment concepts, socio-economic conditions, education level, medical compliance, etc.

　　iii.Some of the above factors can be based on both internal and external factors, such as ethnic differences.

　c)Differences on clinical trial conditions

　　i.Overseas clinical trials need to consider the impact of differences between the test conditions and the correlation between the test data and the expected use population in China. Differences in test conditions include: differences in medical environment, medical facilities, researcher abilities (learning curve), and differences in diagnosis and treatment concepts or guidelines. For example, due to different diagnosis and treatment concepts or standards, the clinical operation methods may not conform to the relevant clinical operation guidelines in China.

　　ii.For clearly defined factors that have a clinically significant impact on the trial data, the applicant can conduct a small-scale clinical trial in China based on the different factors, and combine with the original overseas clinical trial data to confirm the normal use conditions of the device in China.

　　iii.It is recommended that applicants fully communicate with the medical device regulatory authority before submitting overseas clinical trial data, so as to facilitate the scientificity, completeness and full consensus on the clinical evaluation data of the medical device.

4. Services provided by CRCS

CRCS' clinical department and registration department jointly review overseas clinical trial data provided by customers. By comparing clinical trial standards in China and abroad, carefully reading clinical trial protocol and report, ethical opinions, etc. Moreover, we will assess the accuracy and completeness of the overseas clinical data under Chinese standards.