中文版English

Home | Add to Favorites | Contact Us

Home >> Department >> Innovation Platform >> New Drug Safety Evaluation Center, CAMS & PUMC

New Drug Safety Evaluation Center, CAMS & PUMC

 

New Drug Safety Evaluation Center (NDSEC) of Chinese Academy of Medical Sciences & Peking Union Medical College, was established in July 2001, which is linked to the Institute of Materia Medica, Chinese Academy of Medical Sciences, and is the key discipline of the institutions. In order to meet the standards of the international new drug safety evaluation and adapt to the trend of the development of China's new drug safety evaluation, IMM invested in the Union-Genius Pharmaceutical Technology LTD in May 2002, and by the time the center and company commenced integrated operations. The company has earned the title of Beijing Zhongguancun High-Tech enterprise, National Torch Plan Key High-tech enterprise, Zhongguancun biomedical R&D outsourcing alliance governing unit. The company is named by the Beijing Municipal Development and Reform Commission as key technical engineering laboratory on drug safety evaluation in October 2011.
Union-Genius is a CRO engaged in the safety evaluation of health related products, especially of drugs. Union-Genius has already obtained CFDA GLP certification, AAALAC certification, ISO9001: 2008 certification, National measurement certification, the Department of Agriculture's pesticide GLP certification, and National chemical GLP certification etc. The company is the first institution which meets with all the above quality management system certifications in China. Safety evaluation tests are performed for all kinds of new drugs, pesticides, and chemicals safety evaluation test under GLP conditions. The centre (company) is also involved in the study of mechanisms of toxicology effect and the establishment of new techniques and methods. Quality is always our first priority and we aim at preserving an efficient quality assurance system to provide impartial and accurate safety assessments. Our value lies in our exceptional services and our ability to ensure development of safer drugs and help live healthier life.
The lab of company (centre) covers an area of 2000 square meters and a separated Experimental Animal Center with an additional area of more than 3,600 square meters is located in Yizhuang of Beijing. The centre (company) includes the quality assurance department, toxicology department, general management department, management analysis section of the test article, and file management department etc. There are General Toxicology Laboratory, Reproductive Toxicology Laboratory, Genetic Toxicology Laboratory, Clinical Biochemistry laboratories, Pathology laboratories, Immunotoxicity laboratory, Ecotoxicological test laboratory and so on. The main equipments include transmission electron microscope, Leica dual refrigeration automatic constant cold slicing machine, automatic tissue dehydration machine, United CCD image analysis and processing system, fluorescence microscopy, automatic biochemical analyzer and so on.
The company (centre) conducts acute toxicity, chronic toxicity, genotoxicity, reproductive toxicity, local toxicity, immunotoxicity and immunogenicity, safety pharmacology, carcinogenicity, toxicokinetics tests under the principles of GLPs. The company (centre) has completed hundreds of biological products, chemicals and medicine individual or a full set safety evaluation studies. We not only accomplish the new drugs safety evaluation formed and high-leveled, but also focus on the introduction of new technologies and new methods in safety evaluation. We have established drug reproductive toxicity, inhalation toxicity, the percutaneous and special administer toxicity, the toxicity of the photosensitizer evaluation key technology series platform. Some of the key technologies are in leading positions in China. The company (centre) also undertakes the PUMC postgraduate training programs and has two supervisors of drug on toxicology direction.
Strictly following up the objective, impartial and fair principle, NDSEC aims to provide sponsors with real, formed, standard new-drug safety evaluation reports of research data, to provide authentic experimental data and reports to the national drug administration department, dedicated to making contributions to standardization of the new-drugs’ R&D to enhance the level of drug research in China and keeping on earlier realization of internationalization.