Interpretation of Basic Requirements for Clinical Evaluation of In Vitro Diagnostic Reagents Exempted from Clinical Trial (Trial)

Pharmaceutical Network November 9 hearing in order to implement the Central General Office, the General Office of the State Council, "on deepening the reform review and approval system reform to encourage innovation in medical devices," (Office word [2017] 42), and further promote the "takeover" reform Work, promote risk-based product evaluation methods, optimize the allocation of clinical trials and review and approval of resources to promote safe and effective, risk-controlled products to market as soon as possible, the State Food and Drug Administration formulated and released on November 3, 2017 "Free from clinical trials of in vitro diagnostic reagents clinical evaluation of the basic requirements of information (Trial)", since the date of promulgation.

According to the characteristics of in vitro diagnostic reagents, the Measures for Registration of In Vitro Diagnostic Reagents (National Food drug Article 29 of the General Administration of Supervision Order No. 5) clearly stipulates that an in vitro diagnostic reagent that does not require clinical trials should be evaluated by an applicant or a filing a clinical sample covering the intended use and interference factor literature Data and other non-clinical trials to assess the clinical performance of in vitro diagnostic reagents.Therefore, the General Administration released the basic requirements for clinical evaluation of in vitro diagnostic reagents from clinical trials, with the "in vitro diagnostic reagents from clinical trials" Used to guide registered applicants for clinical evaluation of in vitro diagnostic reagents.

The formulation work was started in early 2017 and was solicited in May 2017 for comments. After comprehensively recommending and referring to relevant documents at home and abroad, it was revised and improved repeatedly to be formulated and promulgated on November 3, 2017.

The contents include the scope of application, basic requirements, clinical evaluation methods, test methods, clinical evaluation reports, and other evaluation data in all six chapters, describing the basic requirements of clinical evaluation tests and the relevant requirements of the application materials.The main contents include:

(A) highlighted the main responsibility of the applicant.It is clear that the applicant or commissioned by other agencies or laboratories in China to complete the clinical evaluation, the test process by the applicant to manage the evaluation report by the applicant /proxy People signed, the authenticity of the test data is the responsibility of the applicant.

(2) The retrospective requirements of sample source are emphasized, and the original data of sample (case) should include at least sample source, unique and traceable serial number, age, gender, sample type and sample clinical background information.

(C) to determine the clinical evaluation of the test method can refer to the guidance of the methodological comparison test, and according to product characteristics choose the appropriate statistical methods for statistical analysis, in order to obtain objective and credible results.