Shaanxi Province’s drug GLP certification body achieves a “zero breakthrough”—how significant is this?
Release time:
2020-11-10 19:10
Keywords:
Medications, certification, new drugs, research, clinical trials, safety
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 our province.
Guo Rui Yinuo is an independent, third-party research institution specializing in preclinical safety evaluation of pharmaceuticals. It holds the “License for the Use of Laboratory Animals” issued by the Shaanxi Provincial Department of Science and Technology. The institution officially began preparing for GLP certification for pharmaceuticals in 2020 and, in 2021, submitted applications to the Center for Drug Evaluation of the National Medical Products Administration for GLP certification of its “Genotoxicity Testing Program” (Ames test, micronucleus assay, chromosomal aberration assay) and “Local Toxicity Testing Program.”
During the certification process, the Provincial Drug Administration took “100 Experts Assisting 100 Enterprises” as a key initiative, providing enterprises with dedicated and heartfelt support and guidance. Specifically, regarding the required documentation and relevant procedures for application, the Provincial Drug Administration proactively coordinated and communicated with the National Drug Administration, explained pertinent policies and regulations to enterprises, promptly addressed issues and challenges encountered during document uploads, and made every effort to help enterprises complete their online applications as soon as possible.
Recently, the company successfully passed the on-site inspection and verification conducted by the National Medical Products Administration’s Inspection Center, becoming the first drug non-clinical safety research institution in our province to obtain national GLP certification for pharmaceuticals.
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 development 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 for pharmaceuticals. Previously, our province had no drug safety evaluation centers that had passed the national GLP certification, which severely hindered the research and development of new drugs as well as the commercialization of their scientific findings. The successful certification of Guorui Yinuo will establish a convenient, efficient, and reliable technical platform for new drug R&D and preclinical safety evaluation in our province’s pharmaceutical industry, playing a crucial role in further enhancing our province’s drug R&D capabilities, its independent innovation capacity in the pharmaceutical sector, and the quality of drug research.
Hua Shang Daily reporter Li Lin
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