Safety assessment center of Shanghai Institute of drugs has become a landmark achievement of national major new drug creation science and technology project

Drag "I thought it was just a small laboratory, but I didn't expect you to do so well!" Recently, three inspectors of FDA (food and Drug Administration) gave a very high appraisal to the research center of drug safety evaluation of Shanghai Institute of medicine, Chinese Academy of Sciences: standardized GLP management system, strong quality assurance, well-trained project leader and improved experimental technology team, which effectively guaranteed the preclinical toxicology research Quality As a whole, it is a high-level safety assessment organization   Since it passed the GLP qualification certification of Sweden and Belgium, the member countries of the European Union, and passed the GLP examination of the British drug and health products administration three years ago, the safety assessment center of Shanghai Institute of drugs has become a laboratory that has passed the highest level and the most strict international GLP examination in China, and has reached the international level of non clinical safety assessment research ability and level of international drugs and safety assessment data The important standard of mutual recognition is an important landmark achievement of national major science and technology projects for new drug creation Although it is not early to start, how has the safety assessment center of Shanghai Institute of drugs developed into a "Chinese laboratory" of world trust since its formal establishment in 2002? The content of the examination didn't reveal half a word in advance The reporter put on a white coat and walked into the test article and preparation preparation laboratory of safety assessment center of Shanghai Institute of drugs We can only see that the bottles and cans of various colors are placed in order, the label information such as the expiry date of each bottle of reagent is complete, and some reagents that need to be kept away from light are packed in brown bottles The calibration requirements are indicated on the dose balance on one side, and the last use and calibration date are clearly recorded in the balance work log on August 2 this year Like the reporter's sudden visit, the FDA only informed the safety assessment center of Shanghai Institute of drugs in May this year As for the specific content of the examination, it did not disclose half a word Early on the morning of August 15, three inspectors asked to check the safety evaluation records of a famous pharmaceutical company in 2014, and followed the staff to the archives Don't look down upon this seemingly ordinary room It needs to record the temperature and humidity twice a working day by hand, and the number of air changes should not be less than twice an hour There are also various fire and insect prevention requirements For five days, the inspectors went to every corner of the safety assessment center, checked the operation of many experimental animals and pathological experiments, checked the use and management of many experimental instruments, the records of original data and data storage, and inquired about many experimental project leaders, technical operators and relevant management personnel On the last day, serious prosecutors finally expressed their admiration: it's great! The production technology and diagnosis level of pathology team are quite strong, the operation and maintenance of animal facilities are effective, the cooperation of preparation, biological analysis and clinical examination departments is effective, especially the extensive and skilled use of computerized system, which fully meets the strict requirements of FDA for the safety and reliability of electronic data It is not the first time that the safety assessment center of Shanghai Institute of drugs has experienced such an international GLP examination that more than 10 review "exercises" have been organized, ranging from doubt to admiration, to announcement of passing the audit on the spot This is because the team has been practicing hard for 14 years According to Ren Jin, director of the center for drug safety evaluation, the construction of GLP platform is a complex project Take the standard operating procedures for example There are detailed rules for each small item in each big item The ultimate goal is to make it possible for anyone to follow this rule "We are very lucky to catch up with the time, the place and the people." Ren Jin stressed this on many occasions The center has received continuous support from the Ministry of science and technology in the construction of GLP platform for major new drug creation projects during the 11th Five Year Plan and 12th Five Year Plan In order to have a larger space to build a standardized laboratory, Shanghai Pharmaceutical Institute has eliminated all kinds of difficulties and built a new safety assessment facility in Haike road It is very fortunate that the construction process has also been fully supported by international partners In 2007, AstraZeneca, the fifth largest British pharmaceutical company in the world, was seeking partners in China They visited a number of platforms for two years and finally selected the safety assessment center of Shanghai Institute of drugs This cooperation has greatly improved the international vision of the safety assessment center AstraZeneca has sent 5 resident experts and more than 200 short-term experts to train the staff of the center In those years, everyone calmed down to study, and there was a strong learning atmosphere everywhere After moving into the new facility in 2010, the safety assessment center self pressurized and organized more than 10 review "exercises" From 2012 to 2013, the safety assessment center successfully passed the GLP review of Sweden, Belgium and the United Kingdom In 2013, as the only winner, safety assessment center won the second prize of national science and technology progress award "We can't neglect or relax," said Ren Jin, director of the center for safety assessment and research of Shanghai Institute of medicine, Chinese Academy of Sciences, who was too tired to sleep on the night of passing the FDA audit As the director of the safety assessment center, she led a team of more than 200 people, running all the way for 15 years Once the tense nerves relaxed, she felt tired "It's three poisons For new drugs, the most important thing is safety evaluation to decide whether to enter the clinical We can't neglect or relax " It is with such a new drug dream in mind that Ren entered the "hundred talents plan" of the selected Academy of Sciences in 2001 and came to Shanghai Institute of medicine from Tokyo University For 15 years, as long as she didn't go on business, she was the first one to arrive at the office every day, even on weekends From the first day of entering Shanghai Institute of medicine, Ren Jin made up his mind to "walk on two legs", not only to build an internationally recognized safety assessment platform, but also to make a feature of basic research Now, the safety assessment center has completed more than 80 safety assessment experiments registered in the United States and EU countries, some of which have entered phase I / II clinical trials At the same time, many papers of safety assessment center have been published in international well-known journals Just last month, a paper on anti-tumor drug resistance research just came out As a "leading talent in Shanghai", Ren Jin's leading team won the second prize of national science and technology progress, and also won the Royal College of pathology fellow and international toxicity pathology fellow qualifications, becoming the only Chinese scientist in the international research field who won the title of high-level qualification at the same time In 2015, she won the "science and Technology Progress Award" of Heliang Heli science and Technology Award Fund But what makes her most proud is that she took the lead in building an safety assessment platform and brought out a team with excellent technology Next, she and her team's next goal is to promote the research and development of new drugs in China and promote China's innovative drugs to the international market as soon as possible.