For the implementation of the measures for the administration of the in vitro diagnostic reagents registration, China food and drug verification research institute has released the third phase of the registration of in vitro diagnostic reagents for testing catalogue of national standard substance and reference substance (hereinafter referred to as the "directory"), in vitro diagnostic reagents standard substance varieties increase from 61 to 93.
As early as February 2016, the first phase of the catalogue was released by the central court of inspection, which included the standard material varieties of 42 individual diagnostic reagents. In September 2016, in in vitro diagnostic reagents offices shall, after the establishment in the original varieties, on the basis of updated according to the needs of the development of industry constantly adding new varieties, released in November 2016 the second phase of the "directory", will be in vitro diagnostic reagents standard material varieties increased to 61.
After efforts, the latest issue of "directory" in the second period on the basis of increased 32 varieties, increase the total number to 93, further enrich the varieties of standard substance in vitro diagnostic reagents in our country, the basic coverage of the current market consumption big, wide range of infectious diseases related reference materials. It plays a good role in improving the quality of the product and improving the overall level of the industry.
In addition, in vitro diagnostic reagents offices shall also developed to adapt to a new generation of sequencing technology sequencing machine performance evaluation with deoxyribonucleic acid (DNA) national reference, high-throughput sequencing in peripheral blood of fetal chromosomal aneuploidy (T21, T18 and T13) national reference, pre-implantation chromosome aneuploidy national reference product varieties, etc.
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