Shaanxi’s drug GLP certification body achieves a “zero breakthrough.”
Release time:
2020-11-10 18:10
Keywords:
Institution, drug, certification, clinical, research, safety
According to a report by the China Food and Drug News (reporter He Yichen, correspondent Tian Ye), recently, the National Medical Products Administration awarded Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd. with national drug GLP certification, filling the gap in GLP laboratories in Shaanxi Province.
It is reported that Guorui Yinuo is an independent, third-party research institution specializing in preclinical safety evaluation of drugs. The institution holds the “License for the Use of Experimental Animals” issued by the Shaanxi Provincial Department of Science and Technology. Since officially preparing for drug GLP certification in 2020, the institution submitted its GLP certification applications to the National Medical Products Administration (NMPA) in 2021 for two test projects: the “genotoxicity tests” (Ames test, micronucleus assay, and chromosomal aberration test) and the “local toxicity tests.” During the certification process, the Shaanxi Provincial Drug Administration took the initiative to provide support and guidance to enterprises under the framework of the “Hundred People Assist Hundred Enterprises” program. Specifically, the agency proactively coordinated and communicated with the NMPA regarding the required documentation and relevant procedures, explained pertinent policies and regulations to the enterprises, promptly addressed issues and difficulties encountered during the document upload process, and helped enterprises successfully complete their online applications. Recently, the institution smoothly passed the on-site inspection and verification conducted by the NMPA, becoming the first non-clinical drug safety research institution in Shaanxi Province to obtain national drug GLP certification.
GLP is a fundamental guideline that must be followed in preclinical studies of pharmaceuticals. It encompasses a series of behavioral and laboratory standards for evaluating drug safety in non-clinical research, serving as a critical measure to enhance the quality of new-drug research from the very outset and ensure public medication safety. According to China’s legal requirements, all preclinical safety studies for new drugs must be conducted in laboratories that have obtained national GLP certification. Guo Rui Yinuo has successfully passed the certification, thereby establishing a convenient, efficient, and reliable technical platform for new drug development and preclinical safety evaluation within Shaanxi Province’s pharmaceutical industry. This will play an important role in further elevating Shaanxi Province’s drug R&D capabilities, enhancing its independent innovation capacity in the pharmaceutical sector, and improving the overall quality of drug research.
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