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Xinhua News Agency, Beijing, February 23 (Chen Fang, Cui Can) to carry out more than 3500 drugs in non-clinical safety evaluation study, 128 kinds of toxic risk drugs to enter the clinical, 11 platform through the International Laboratory Animal Assessment and Accreditation Committee certification ... ... From the Ministry of Science and Technology information,for a period of time, China's drug non-clinical safety evaluation platform (GLP) has made a series of major breakthroughs, effectively avoiding the high toxicity of serious drugs into clinical.
In order to enhance the innovation ability of the biomedical industry, in recent years, China has implemented the "new technology to create a national science and technology major project." New drug creation special technical master, Chinese Academy of Engineering Sang Guowei introduction, non-clinical safety evaluation refers to the drug into clinical trials before the safety assessment. Without the link of the drug, can not enter the human body test.
As a new drug to create special results, GLP platform to carry out more than 3500 drugs non-clinical safety evaluation study, which are not listed at home and abroad are not more than 1,400 innovative drugs. Drug evaluation period, the platform found a total of 128 kinds of drugs serious toxicity Risk, and suggested that the client to terminate the drug research and development, to avoid access to clinical, effective protection of the public drug safety.
The platform has broken through the key technologies of immunotoxicity assessment, biodistribution research and tissue cross-reflection research, and has built the fourth laboratory in the world to carry out cynomolgus monkey development and reproductive toxicity evaluation. A series of core technologies have reached the international advanced level.To carry out non-clinical safety evaluation of emerging drugs provides an important technical support.
"Part of the GLP platform technology has also extended to the pesticide, animal food, veterinary drugs and environmental toxicants and other fields, led the development of other industries norms." Sang Guowei said, "thirteen five" period, the new drug creation will continue to focus on "new drugs "and" security "of the strategic needs, to further enhance China's GLP platform the ability of innovation.
It is understood that, GLP platform full-time practitioners from the "15" at the end of the more than 600 people increased to more than 2100 people, platform training drug non-clinical safety evaluation of 42 academic leaders in the field, the national new drug review experts 40, talent growth effective help the industry's vigorous development.In addition, the GLP platform core laboratory in the area the basis of the original 60 thousand square meters added more than 15 square meters, more than 3,000 sets of equipment (sets), worth nearly 360 million yuan.
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