In order to implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices" of the Central General Office and the General Office of the State Council (Trade [2017] 42), the reform of "decentralized service" was further promoted and risk-based products were promoted. Evaluation methods, optimized allocation of clinical trial and review and approval resources, and promotion of safe, effective, and risk-controllable products to market as soon as possible. The State Food and Drug Administration organized the formulation and issued the "Exempt from clinical trials on November 3, 2017" Basic Requirements for Clinical Evaluation of In Vitro Diagnostic Reagents (Trial) "will be implemented from the date of publication.

I. Background

According to the characteristics of in vitro diagnostic reagent products, Article 29 of the "Administrative Measures for the Registration of In vitro Diagnostic Reagents" (Order of the State Food and Drug Administration No. 5) issued in 2014 clearly stipulates that in vitro diagnostic reagents that do not require clinical trials, apply The person or the recorder shall evaluate the clinical performance of the in vitro diagnostic reagent by means of non-clinical tests such as the evaluation of clinical samples that cover the intended use and interference factors, and comprehensive literature. Therefore, the General Administration issued the basic requirements for the clinical evaluation of in vitro diagnostic reagents exempted from clinical trials, and used it in conjunction with the Catalog of In vitro Diagnostic Reagents Exempted from Clinical Trials.
制定 The formulation work was started in early 2017, and comments were sought in May 2017. After comprehensive suggestions and references to relevant domestic and foreign literature, it was repeatedly revised and improved and formulated. It was released and implemented on November 3, 2017.

Twenty-two, the main content

The content includes six chapters, including the scope of application, basic requirements, clinical evaluation approaches, test methods, clinical evaluation reports, and other evaluation materials. It describes the basic requirements for clinical evaluation trials and the relevant requirements for application data. The main contents are:
(1) The applicant's main responsibility is highlighted. It is clear that the applicant completes the clinical evaluation work in China by itself or entrusts other institutions or laboratories, the test process is managed by the applicant, the evaluation report should be signed by the applicant / agent, and the applicant is responsible for the authenticity of the test data.
(2) The requirement of traceability of the sample source was emphasized. It is required that the raw materials for evaluation samples (cases) include at least the source of the sample, a unique and traceable number, age, gender, sample type, and clinical background information of the sample.
(3) The test method for clinical evaluation is specified. Experiments can be conducted with reference to the relevant methodological comparison guidelines, and appropriate statistical methods can be selected for statistical analysis based on product characteristics in order to obtain objective and credible results.