National Center for New Drug Safety Evaluation and Research in Shenyang

 

The safety evaluation center of Shenyang Chemical Research Institute (the “Safety Evaluation Center”) was built up and officially put into operation in 1986 and subject to several expansions afterwards. In 1997, the Safety Evaluation Center was certified as “Pesticide Safety Evaluation & Quality Supervision and Inspection Center for Chemical Industry” by the former Ministry of Chemical Industry. In 2001, it was recognized as “National Center for New Drug Safety Evaluation and Research in Shenyang” by the Ministry of Science and Technology. In May 2003, it was one of the first pilot units certified for Good Laboratory Practice (GLP) for non-clinical drug research by State Food and Drug Administration, and became one of the first 4 GLP standard organizations of non-clinical drug safety evaluation in China. In 2004, it won new qualifications from the Ministry of Agriculture and State Environmental Protection Administration, and received the title plate reading “Liaoning New Drug Safety Evaluation Technology Research Center” issued by Liaoning Science and Technology Bureau. In 2008, it passed the on-site GLP assessment by the Ministry of Agriculture for pesticide environmental evaluation and residue test, as well as Ministry of Environmental Protection’s inspection for experimental unit for eco-toxicological testing of new chemical substances. In May 2010, the Safety Evaluation Center, together with the other five units, was accredited by the Ministry of Agriculture as China’s first batch of GLP pesticide laboratories. In 2012, the safety evaluation center passed GLP certification and recognition of the Netherlands government, a member of OECD, making the safety evaluation center the first organization in China to pass such international certification.

The Safety Evaluation Center is mainly engaged in the safety evaluation and research on pesticides, pharmaceuticals and other fine chemicals. Through experiments and studies on various laboratory animals, it aims to discover the toxic effect and genital impact on the animals, evidences of carcinogenicity, and damage to the ecological environment of the chemicals, so as to provide a scientific basis for the protection of human health and ecological environment. Safety evaluation is an important and indispensable part in the process of commercialization of all kinds of chemicals. After the incessant exploration and improvement in recent years, the Safety Evaluation Center now has a well-established organizational system, a complete professional and technical team, advanced specialized instruments and equipment, and improved laboratory facilities and management. As meeting the international standards, the Center is capable of a full set of tests of non-clinical safety evaluation for drug registration, and is currently China’s only organization qualified for safety evaluation tests for pesticides, pharmaceuticals and other fine chemicals simultaneously. For over ten years, the Center has undertaken and completed a large number of safety evaluation tests for various pesticides, pharmaceuticals and chemicals at home and abroad, and established a comprehensive safety evaluation technology platform serving domestic and international clients. The test data and reports have been recognized by the Ministry of Agriculture and State Food and Drug Administration, as well as relevant authorities in some countries and regions.

In 2012, the Safety Evaluation Center passed GLP certification and recognition of the Netherlands government, a member of OECD, making the center one of the first organizations of its kind in China to pass such international certification.