Bi Jingquan: improve the quality of drugs with strict standards

[expert opinion of chinapharma.com] director Bi Jingquan of the State Food and Drug Administration told the participants at the founding meeting of the 11th Pharmacopoeia Committee that the Pharmacopoeia Committee is not only a resounding honor, but also a heavy responsibility The compilation of pharmacopoeia is the contribution of modern "xuanhu Jishi" Every member of the committee should adhere to a scientific attitude, dare to take responsibility, strengthen the system construction, and uphold the integrity of professional ethics (director Bi Jingquan made an important speech at the conference photo source: CFDA) recently, the founding conference of the 11th Pharmacopoeia Committee was held in Beijing This Pharmacopoeia Committee is composed of 405 expert members Director Bi Jingquan of the State Food and drug administration is the chairman of the 11th Pharmacopoeia Committee, deputy director Wu Zhen of the State Food and drug administration is the standing vice chairman, Zhang Boli, academician of the Chinese Academy of engineering and President of the Chinese Academy of traditional Chinese medicine, Chen Kaixian, academician of the Chinese Academy of Sciences and Shanghai Institute of pharmaceutical research of the Chinese Academy of Sciences, academician of the Chinese Academy of engineering Cao Xuetao, President of the Chinese Academy of Medical Sciences, was appointed vice chairman 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 At this critical period of the reform of the preparation of the new edition of Pharmacopoeia, director Bi Jingquan highlighted the main tasks of the Committee: to deploy the preparation of the 2020 edition of China Pharmacopoeia, promote the reform of drug standards, strengthen the whole process management of drug standards, and promote the further improvement of drug quality In his speech, director Bi Jingquan stressed the importance of fully understanding the drug standards Drug supervision is the work highly valued by the CPC Central Committee and the State Council Up to now, ten editions of Pharmacopoeia have been promulgated and implemented in China Drug standards have played an important role in improving the quality of drugs and promoting the transformation and upgrading of the pharmaceutical industry However, due to the limitation of historical conditions, there are some problems such as lack of drug standards, backward standards, ineffective standards and inadequate implementation of standards The compilation of the new edition of Pharmacopoeia should serve the drug supervision, reform and innovation, the development of the pharmaceutical industry, the encouragement of good drugs, the elimination of bad drugs, and the identification of inferior and fake drugs Director Bi Jingquan asked 405 members to seriously study several issues: the positioning of Pharmacopoeia; the essential characteristics of modern medicine and traditional medicine, as well as the differences between modern medicine and traditional medicine, carefully summarize the experience and lessons of natural drug development and research in recent years, inherit and develop traditional medicine; research the relationship between new drug listing standards, orange peel book and pharmacopoeia New drugs approved and listed by regulatory authorities are original and benchmarking, and their applications are protected by law After the expiration of the period, enterprises applying for the production and listing of generic drugs can borrow the achievements and data of the original research enterprises to avoid re conducting large sample clinical trials The regulatory department reviews the pharmaceutical equivalence and bioequivalence of the original research drugs according to the standards of the original research drugs The equivalence of the two is regarded as the efficacy equivalence and can be replaced in the clinical bed; This paper studies how to break the "hidden rules" of adulteration and forgery in Pharmacopoeia preparation to serve the supervision Plug the loopholes in time and crack the "hidden rules" Director Bi Jingquan stressed that the reform achievements should be reflected in the revision of Pharmacopoeia to serve the reform and innovation Since 2015, the General Administration has earnestly implemented the decision-making and deployment of the Party Central Committee and the State Council, and comprehensively promoted the reform of drug review and approval system with relevant departments The reform is not limited to review and approval, but gradually expanded to a comprehensive reform of the drug regulatory system The overall goal of the reform is to be in line with international standards 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 In terms of system, we should encourage drug innovation and imitation; ensure the fairness and justice of the evaluation system; realize the whole life cycle management of drugs; ensure the authenticity, integrity and traceability of clinical trial data; ensure that the processing process conforms to GMP standards, and ensure the authenticity, integrity and traceability of data After the speech, director Bi Jingquan earnestly warned everyone that the members of the Pharmacopoeia are not only a resounding honor, but also a heavy responsibility The compilation of pharmacopoeia is the achievement of modern "serving the world with a pot" Every member of the committee should adhere to a scientific attitude, dare to take responsibility, strengthen the system construction, and uphold the integrity of professional ethics Only in this way can Pharmacopoeia work guarantee drug quality, support drug supervision, industrial development, and make new contributions to the health cause of the Chinese nation Director Bi Jingquan's speech has aroused great repercussions in the industry and greatly encouraged many senior people in the Chinese pharmaceutical industry "In the past two years, the General Administration has vigorously promoted the comprehensive reform of review and approval, and the requirements for drug quality and safety have been continuously improved Director Bi's speech on the compilation of the new pharmacopoeia also shows that the Chinese Pharmacopoeia has started the process of standard modernization and is in line with the international standards, which is a great encouragement for pharmaceutical enterprises, especially for innovative drug research and development enterprises like us " Dr Jiang Ningjun, executive officer of cornerstone pharmaceutical, praised it "The improvement of Pharmacopoeia standards is a process of continuous renewal and progress," he said For enterprises, the modernization of Pharmacopoeia means the continuous upgrading of technology, which brings some challenges to some domestic enterprises But for the public, especially for patients, because of the strengthening of drug testing and supervision by the regulatory authorities, the safety of patients' drug use has a more comprehensive guarantee, which is also conducive to China's innovative drug products going to the world " "Hualing pharmaceutical is a pilot unit of CFDA promoted drug listing license holder system, and a direct beneficiary of the reform program," said Dr Chen Li, general manager and co-founder of Hualing pharmaceutical "With the entry of diabetes innovative drugs into the registered clinical trials, Hualing pharmaceutical has obtained the qualification of the holder, enabling innovative enterprises to cooperate with CMO and drug manufacturers to achieve drug production And industrialization, integrated with the international pharmaceutical value chain, ensure the interests of patients and the needs of enterprise development! The holder of marketing license is the person responsible for the entire life cycle of drug research and development, production and sales, which puts forward clear requirements for the pharmaceutical industry and provides protection for overall health " "With the increasing trend of global aging, the big health industry will also take off The revision of the new pharmacopoeia is of great historical significance to China and the international medical and health industry President Bi clearly stressed that the reform of drug regulation with high standards and strictness will set the tone for the transformation of China's pharmaceutical industry to international innovation and research and development, and pointed out the direction for the future development of China's pharmaceutical industry on the international stage, which is of great significance, "said Dr Liu busjun, vice president of Wuxi Wuxi Pharmaceutical Co., Ltd and operation officer of the testing business division," Wuxi Pharmaceutical Co., Ltd has always been committed to the construction of the company The international standard R & D and production service platform strictly controls the quality, and our high-quality service has won the unanimous recognition of regulatory agencies and the industry We believe that in the future, we will cooperate with more domestic manufacturers, as a strong booster for the development of China's pharmaceutical industry, and make our contribution to the healthy and rapid development of China " In recent years, under the major national policies of benefiting the country and the people, both practical and forward-looking, the State Food and drug administration has vigorously launched a series of major new drug innovation measures to encourage innovation, and is committed to putting high-quality new drugs on the market as soon as possible, so that the Chinese people can use them with confidence, availability and availability China's pharmaceutical industry is ushering in another spring, a vibrant innovation ecosystem is forming, and innovation China is confidently moving to the world stage Inspired by the national policy and the innovation and reform of the State Food and drug administration, Wuxi Pharmaceutical Co., Ltd is looking forward to working with all colleagues to seize the opportunity given by the times, bring new and good medicines and health products to patients around the world, and realize the dream of "no hard medicine, no hard disease in the world" Original title: Director Bi Jingquan's important speech: improve drug quality with strict standards Seize the opportunity of pharmaceutical machinery and equipment industry, please download app (Pharma, Android version)!