Solve the standard problem and complete the preparation of Chinese pharmacopoeia in 2020 with high quality
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Last Update: 2017-08-31
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Source: Internet
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Author: User
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[China Pharmaceutical network industry trends] up to now, China has promulgated and implemented ten editions of Pharmacopoeia The drug standards have been developed from scratch, the number of products collected has been reduced to many, and the standard level has been reduced to high, which has played an important role in improving the overall drug quality level of China and promoting the transformation and upgrading of the pharmaceutical industry At present, the preparation of Chinese Pharmacopoeia 2020 is in progress (solve the standard problems and complete the preparation of Chinese pharmacopoeia in 2020 with high quality source: Baidu pictures) Bi Jingquan, director of the State Food and drug administration, said recently that it is necessary to speed up the formulation and revision of drug standards, establish a scientific, comprehensive, testable and enforceable standard system, improve the quality and efficacy of drugs with "rigorous standards", prevent drug safety risks and ensure the safety of drug use by the masses Bi Jingquan said at the 11th Founding Conference and plenary session of the Pharmacopoeia Committee held recently that there is a gap between the quality and efficacy of drugs in China and the United States, Europe and Japan, largely because of the low standards for drug listing, the lack of standards, the backward standards, the ineffective standards, and the inadequate implementation of standards The Pharmacopoeia Committee should boldly learn from the advanced achievements and experience of the development of International Pharmaceutical Science and technology, solve the problems in drug standard work, and complete the task of Pharmacopoeia compilation with high standards and high quality The preparation of Chinese Pharmacopoeia 2020 is in progress Bijingquan said that the pharmacopoeia is the crystallization of the achievements in the development of pharmaceutical science and technology, the symbol of the development level of a country's pharmaceutical industry, the basic compliance of pharmaceutical producers and operators, and the guideline of pharmaceutical supervision Up to now, China has promulgated and implemented ten editions of Pharmacopoeia, which plays an important role in improving the quality of drugs and promoting the transformation and upgrading of pharmaceutical industry In view of the reform in the field of drugs, Bi Jingquan pointed out that China's drug reform has gradually expanded from the reform of the review and approval system to the comprehensive reform of the drug regulatory system He stressed that the basic standard for drug marketing is that new drugs should be "global new", and generic drugs should be consistent with the quality and efficacy of the original drugs It is necessary to realize the whole life cycle management of drugs and the supervision of the whole chain of drug research and development, processing, distribution and use The holder of drug approval documents shall bear the legal responsibility for the whole life cycle of research and development, processing, distribution, adverse reaction monitoring, and improvement of drug quality All applications with untrue, incomplete and non traceable clinical trial data shall be returned The Pharmacopoeia of the people's Republic of China, 2015 edition, is the 10th edition since the founding of new China The total number of drugs recorded in this edition of Chinese pharmacopoeia is 5608, covering basic drugs, categories of medical insurance catalogue and commonly used clinical drugs Former title: General Administration of food and drug: establishing a scientific drug standard system to make up the shortcomings Author: Chen Cong
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