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[Summary description] China Food and Drug network news (reporter He Yichen correspondent field) Recently, the State Food and Drug Administration issued the national drug GLP certification to Xixian New District Guorui Ynuo Drug Safety Evaluation Research Co., LTD., filling the gap in Shaanxi GLP laboratory

China Food and drug network news (reporter He Yichen correspondent field) Recently, the State Food and Drug Administration issued the national drug GLP certification to Xixian New District Guorui Ynuo Drug Safety Evaluation Research Co., LTD., filling the gap in Shaanxi GLP laboratory.

It is reported that Guorui Yinuo is an independent third-party drug preclinical safety evaluation research institution, with the "Experimental animal use license" issued by the Science and Technology Department of Shaanxi Province, the institution has officially prepared for drug GLP certification since 2020. And submitted to the State Food and Drug Administration in 2021 "genotoxicity test project" (Ames, micronucleus, chromosome aberration) and "local toxicity test project" GLP certification application. During the certification process, the Shaanxi Provincial Food and Drug Administration takes "100 people to help 100 enterprises" as the starting point, provides assistance and guidance for enterprises, takes the initiative to communicate with the State Food and Drug Administration for the required information and relevant procedures, explains relevant policies and regulations to enterprises, timely solves the problems and difficulties encountered in the transmission of information, and helps enterprises successfully complete the online application. A few days ago, the agency successfully passed the on-site inspection and verification of the State Food and Drug Administration, and also became the first drug non-clinical safety research institution in Shaanxi Province to pass the national drug GLP certification.

GLP is a basic guideline that must be followed for drug preclinical research, including a series of behavioral and laboratory requirements for drug safety evaluation in non-clinical drug research, and is a fundamental measure to improve the quality of new drug research at the source and ensure public drug safety. According to China's legal requirements, all preclinical safety studies of new drugs must be conducted in laboratories that have obtained national drug GLP certification. The successful certification of Guorui Yinuo will build a convenient, efficient and reliable technology platform for the research and development of new drugs and preclinical safety evaluation of the pharmaceutical industry in Shaanxi Province, and play an important role in further improving the level of drug research and development in Shaanxi Province, the independent innovation ability of the pharmaceutical industry, and the quality of drug research.