We warmly celebrate Guorui Yinuo’s successful attainment of the Veterinary Drug GLP Certification from the Ministry of Agriculture and Rural Affairs of the People’s Republic of China.
Release time:
2022-08-23 13:58
Keywords:
On August 22, 2022, the website of the Ministry of Agriculture and Rural Affairs of the People's Republic of China released the "Notice from the Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs on the Publication of the Inspection Results (26th Batch) of the Quality Management Standards for Non-Clinical Research and Clinical Trials of Veterinary Drugs," which clearly stated that seven trial projects of Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd. (hereinafter referred to as "Guorui Yinuo") meet the requirements of the Quality Management Standards for Non-Clinical Research of Veterinary Drugs.
The seven test projects submitted by Guorui Yinuo this time are as follows: acute toxicity test (rodents), subchronic toxicity test (rodents), genotoxicity test (Ames test), genotoxicity test (micronucleus assay), genotoxicity test (chromosomal aberration assay), genotoxicity test (sperm malformation assay), and local toxicity test.
Veterinary medicine GLP Overview:
GLP is an abbreviation for Good Laboratory Practice. Veterinary GLP, or the Quality Management Standards for Non-Clinical Studies of Veterinary Drugs, is a set of guidelines established in accordance with the "Regulations on the Administration of Veterinary Drugs" to enhance the quality of non-clinical studies of veterinary drugs, ensure the authenticity, integrity, and reliability of experimental data, and guarantee the safety of veterinary drugs. According to Announcement No. 2464 issued by the Ministry of Agriculture: As of January 1, 2018, any veterinary drug products that have not been approved... Veterinary drug safety evaluation institutions that have failed inspections or supervisory checks conducted by the Ministry of Agriculture and Rural Affairs shall not use their completed research and experimental data in applications for veterinary drug registration. This imposes higher requirements and stricter regulations on clinical trials for future new veterinary drug registration applications. As indicated in the announcement from the Ministry of Agriculture and Rural Affairs, the state will further strengthen its oversight over veterinary drug registration and the issuance of approval numbers for veterinary drug products. Starting from January 1, 2018, clinical trial data submitted for veterinary drug registration and approval number issuance must be provided by third parties with no conflicts of interest. This represents both a new challenge and an opportunity for many veterinary drug R&D and manufacturing enterprises. The best way to meet this challenge is to thoroughly learn and strictly comply with the GLP/GCP management systems for veterinary drugs.
Introduction to the Ministry of Agriculture and Rural Affairs:
The Ministry of Agriculture and Rural Affairs is a constituent department of the State Council and operates at the vice-ministerial level. The Ministry of Agriculture and Rural Affairs implements the Party Central Committee’s policies on... The guiding principles, policies, and strategic decisions for “agriculture, rural areas, and farmers” work must uphold and strengthen the Party’s centralized and unified leadership over this work in the course of fulfilling our duties.
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