China's new drug safety assessment is in line with the international standards, and 30 original new drugs will be tackled in the 13th five year plan

          It was learned at the press conference of national science and technology major project of major new drug creation (hereinafter referred to as "new drug project") that China's preclinical safety assessment of new drugs has been in line with the international standards, and the core key technologies of GLP platform have reached the international advanced level, which not only provides safety assessment services for domestic and foreign pharmaceutical enterprises, but also accelerates the domestic new drug development Enter the international mainstream market Non clinical safety evaluation of drugs mainly refers to animal test, which is the front link of human test, directly related to the success or failure of new drug development and public drug safety "Our task is to produce 30 real new drugs during the 13th Five Year Plan period." Academician sang Guowei, Chinese Academy of engineering GLP platform construction promotes new drug research and development It is reported that from the 11th five year plan to the 12th Five Year Plan, China has launched a total of 25 new drugs, five times the number of new drugs developed in China after liberation Sang Guowei stressed that "new drug" refers to the original new drug that has not been listed at home and abroad before According to him, 30 new drugs include about 10 biological agents, vaccines and antibodies, 10 chemical new drugs, 10 traditional Chinese medicine compounds, famous prescriptions and proven prescriptions The R & D cycle of these new drugs is long and short, which has considerable technical difficulties "In general, the research and development of new drugs in China is much better than before At present, six kinds of new drugs have been transferred to the international market, with a maximum of US $1.5 billion, which was unimaginable before " Sang said The process of new drug research and development and entering the international market is accelerated thanks to new drug projects Qin Huaijin, director of the new drug implementation and management office and director of the science and Education Department of the health and Family Planning Commission, said at a press conference on the 22nd that according to preliminary statistics, the central government has invested 12.8 billion yuan in new drug projects, and now has realized more than 160 billion yuan of direct economic benefits The new drug project was initiated in 2008 under the leadership of the former Ministry of Health (now the state health and Family Planning Commission) and the former General Logistics Department of the Central Military Commission (now the logistics support department), in accordance with the outline of the national medium and long term science and technology development plan (2006-2020) According to Qin Huaijin, the goal of the new drug program is to independently develop and technically transform a batch of drugs to improve the national drug innovation system for 10 major diseases such as malignant tumors The premise of R & D of innovative drugs is safety evaluation (hereinafter referred to as "safety evaluation") Safety score is divided into animal test and human test Only drugs that have completed animal test can enter human test stage Since the 1970s, the United States, Japan and European countries have formulated quality management standards (GLP) for non clinical drug research, which requires that GLP must be implemented in preclinical safety evaluation of registered new drugs, so as to ensure the authenticity, accuracy and reliability of drug safety evaluation results According to Sang Guowei, since the implementation of the new drug program in 2008, 13 GLP platforms and 19 related key technology researches have been deployed and supported in China At present, 11 of the 13 platforms have passed the AAALAC certification, 3 platforms have passed the cap certification, and 9 platforms have established LIMS system for laboratory data collection and management according to international standards, marking that the evaluation ability of domestic GLP platform has reached the international level At present, the GLP platform in China has broken through a series of representative key core technologies such as immunotoxicity evaluation, biological distribution research and tissue cross reaction research by further improving the non clinical safety evaluation technology system of drugs, said sang "The development and improvement of China's GLP industry has further accelerated the entry of domestic new drugs into the international mainstream market." Sang said Strict prevention of drug damage: China is currently experiencing the stage of imitation as the leading combination of creation and imitation At present, the main means to strictly control the quality standard of generic drugs is to carry out the consistency evaluation of generic drugs The purpose of consistency evaluation of generic drugs is to make the generic drugs on the market in China consistent with the original drugs in terms of quality and efficacy, and to be able to replace each other in clinical It is reported that in addition to the GLP project for new drug research and development, the new drug project has also set up a consistency evaluation project At present, there are more than 5000 domestic enterprises that have passed the new GMP certification In addition to several enterprises with strong R & D capabilities, other enterprises need the technical support of the corresponding platform for new drugs Another link to control the quality and safety standards of drugs is to study the possible toxic effects and mechanisms of drugs, so as to prevent the occurrence of major "drug harm" events at home and abroad It is reported that up to now, a total of 128 evaluation drugs have been found in the GLP platform research Through the risk assessment, the entrusting party is recommended to terminate the drug research and development, so as to avoid the drugs with serious toxicity entering the clinic Sang Guowei said that during the 13th Five Year Plan period, the special award for new drugs continued to focus on the demand for "new drugs and safety protection", aiming at the weak links of domestic drug toxicology research, and further improved the innovation ability and international competitiveness of China's GLP platform Source: 21st century economic news