National Zhejiang Center for
Safety Evaluation of New Drugs

National Zhejiang Center for Safety Evaluation of New Drugs was founded in 1997 with affiliation to Zhejiang Academy of Medical Science. The Center is dedicated to carrying out various preclinical safety evaluation for new drugs, including chemical medicine, Chinese herbal medicine, natural medicine, bio-medicine, as well as iatric products etc. It is the only institution of preclinical safety evaluation in compliance with Good Laboratory Practice（GLP） in Zhejiang Province. The Center has been first awarded GLP certification in Aug. 2000 by the Ministry of Science and Technology, and awarded with State Food and Drug Administration (SFDA, China) GLP Lab Certification in Jul.2004. At present the Center is main member of two Technical Platforms, namely the Technical Platform for New Drugs R&D of Zhejiang Province and the Technical Platform for laboratorial animals of Zhejiang Province, and was ranked as Research Center for Safety Evaluation of Modern Chinese Medicine, National TCM Modernization Technological Industrial (Zhejiang) Base.

Current Service Items
Being provided with the conditions of hardware and software, the Center presently can carry out various safety evaluations for drugs mainly, also including materials applied directly or indirectly to human. Safety studies: single dose toxicity test, repeated dose toxicity test, local toxicity test, genotoxicity test, reproduction toxicity test, immunotoxicity test, safety pharmacology test, pharmacokinetics & toxicokinetics test, etc.

Major Achievements of Research
From Oct. 1997 to Dec. 2006, more than 2000 safety evaluation studies were completed, which involved in 158 kinds of new drugs and 7 kinds of iatric products. All of these studies received successful evaluation from SFDA. 7 safety studies of one kind of Class I Chinese herbal medicine, which has been launched in USA as a health food, were awarded the FDA certifications. 20 safety studies based upon two kinds of new chemical drugs were accomplished according to the requirements of FDA. Additionally, the safety evaluation studies of iatric products were accepted by Germany and Japan, and received high praise in autoptic checking in 2000.

Hardware Conditions
1. The new GLP lab buildings, with an area of 7986 square meters, consist of 3600 square meters of animal labs，which prepare for conventional and SPF animals, and all kinds of advanced function labs, among which we have 127 square meters cleanrooms.
 2. The Center is now equipped with over 100 kinds of advanced apparatus, most of which are from abroad, used in safety evaluating studies.

Software Conditions
1. The Center has established a comparatively perfect laboratory organization and management system and a full set of effective QA system. 68 management systems, 5 kinds of standard labels, 348 SOPs，over 120 record forms and 120 QAU inspection tables have been drawn up.
2. Elementary data of physiological and biochemical for laboratory animal used in drug safety assessment were gathered.
3. The Center has a skilled, united, steady and young scientific research group, whose members all grasp profound GLP foundation and operation knowledge.

According to our working principles of pursuing authenticity and assuring quality, we sincerely hope to cooperate with overseas and domestic new drugs research & development enterprises or institutions. So far, the Center has established good cooperation with over 60 scientific research institutions, colleges, academies and pharmaceutical enterprises countrywide. It is now the permanent contract laboratory of a Foreign Invested Enterprise. We would like to contribute our strength to the health of the human being, with our friends.