Guideline For Comparing The Same Variety Of In-vitro Diagnostic Reagents Exempted From Clinical Trials (draft)
2021-06-22
I. Purpose of Compilation The comparison of the same variety of in vitro diagnostic reagents in this Guidelines refers to: for in vitro diagnostic reagents that are exempt from clinical trials, the applicant will make a methodological comparison between the in vitro diagnostic reagent for testing and a product of the same variety marketed in China under the background of non-clinical trials to prove that in vitro diagnostic reagent for testing is essentially the same as the marketed product. The purpose of the guideline is to provide technical guidance for the applicants to compare in vitro diagnostic reagents that are exempted from clinical trials with the same variety of products, and to provide a basis for the technical review of this part of the data by the drug regulatory authorities. II. Legal Basis (i) Regulations for the Supervision and Administration of Medical Devices. (ii) Provisions for In Vitro Diagnostic Reagent Registration. III. Scope of Application This Guidelines is applicable to the comparative study on Class II and Class III in vitro diagnostic reagents which are exempted from clinical trials and the same variety of marketed products. For in vitro diagnostic reagents that are exempted from clinical trials, the applicant shall submit the basis for determining the exemption of the reagent from clinical trial. For in vitro diagnostic reagents that are exempted from clinical trials, the applicant can conduct a comparative study on the in vitro diagnostic reagent and a product of the same variety according to the requirements of this Guidelines, or conduct a clinical trial according to the requirements of the Guideline for Clinical Trials of In-vitro Diagnostic Reagents. IV. Basic Principles For Class II and Class III in vitro diagnostic reagents which are exempted from clinical trials, the applicant can compare the in vitro diagnostic reagent for testing with the product of the same variety marketed in China to prove that the in vitro diagnostic reagent for testing is essentially the same as the marketed product. The applicant should have completed all other performance evaluations of the in vitro diagnostic reagent for testing before conducting the comparative study, and have a full understanding of the performance of the in vitro diagnostic reagent for testing, so as to provide a basis for the comparison of the in vitro diagnostic reagent for testing with the marketed product of the same variety. If the comparative study fails to prove the in vitro diagnostic reagent for testing is essentially the same as the marketed product of the same variety, the in vitro diagnostic reagent for testing should be evaluated in the form of clinical trial. V. Specific Requirements for Comparative Study (i) Selection of contrast reagents For in vitro diagnostic reagents that are exempted from clinical trials, if the method described in this Guidelines is used to make the comparative study, the domestically marketed products commensurate with the in vitro diagnostic reagent for testing should be determined as the comparative reagent by comparative analysis. The applicant should first compare the intended use between the in vitro diagnostic reagent and the product of the same variety already marketed in China.Intended use refers to the general use or function of an in vitro diagnostic reagent, including sample type, object to be tested and indications.Indications refer to diseases or conditions that are diagnosed, prevented, predicted, monitored for treatment or observed for prognosis by in vitro diagnostic reagents, including the applicable population.If the intended use of the in vitro diagnostic reagent for testing falls within the scope of the intended use of a product already marketed in China, the two are considered to have the same intended use.If there are functional differences between the in vitro diagnostic reagent for testing and the product marketed in China (e.g. for auxiliary diagnosis and treatment monitoring respectively), and applicable population differences (e.g. for adults and children respectively), it is considered that they have different intended uses. On the premise that the in vitro diagnostic reagent for testing has the same intended use of the product marketed in China, the applicant should continue to make a comparative analysis of the basic principles, main components, performance indicators, positive judgment values or reference intervals and testing methods between them.If there are differences, the applicant should further assess whether the differences will have a significant impact on their performance in testing human samples.If the differences between them do not have a significant impact on their performance in testing human samples, they are considered comparable.If the basic principles (methodologies) of the two are quite different from each other (such as chemiluminescence and immunoturbidimetry) or their performance indicators are quite different, they are considered uncomparable. The product of the same variety marketed in China can be used as contrast reagent when it meets the following conditions at the same time:
Approved to be marketed in China;
It has the same intended use as the in vitro diagnostic reagent used for testing;
The differences between it and the in vitro diagnostic reagent for testing will not have a significant impact on their performance in testing human samples;
It has good clinical applications, and its product quality is good based on the existing technology level;
For quantitative reagents, the testing results of the contrast reagent and the in vitro diagnostic reagent for testing should have the same unit of measurement or the unit of measurement between them can be converted into each other. (ii) Testing site The applicant may complete the trial independently or commission other competent laboratories to complete the trial according to the characteristics of the product. The trial process is managed by the applicant, and the applicant should be responsible for the authenticity, reliability and integrity of the trial data. Overseas applicants shall conduct trials in China through their agents in China. (iii) Testing personnel The trial operator shall be a professional and technical person with corresponding trial ability and be familiar with the testing process of the in vitro diagnostic reagent for testing and the contrast reagent.
