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    Home > Active Ingredient News > Antitumor Therapy > Experts call attention to the whole life cycle management of anti-tumor drugs to establish and improve the quality management system.

    Experts call attention to the whole life cycle management of anti-tumor drugs to establish and improve the quality management system.

    • Last Update: 2020-07-28
    • Source: Internet
    • Author: User
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    In the third batch of national organizations of drug centralized procurement to promote the transformation and upgrading of the pharmaceutical industry at the same time to ensure the quality and safety of drugs more and more attention from all walks of lifeExperts here called for attention to the full life cycle management of anti-tumor drugsProfessor Xu Binghe, Director of the National Clinical Research Center for Pharmaceutical Anti-Oncology drugs and Professor of Oncology Hospital of the Chinese Academy of Medical Sciences, said that in recent years, with the increasing availability of cancer drugs and the speed of the introduction of innovative drugs, more and higher quality anti-tumor drugs can be used by cancer patientsHowever, drug management problems are also becoming increasingly prominent, such as irregular drug use, regional management differences, such as the urgent need to introduce anti-tumor drug use principles and guidelines to establish and improve the quality management system to consolidate the efficacy and safety of drugs"The outbreak of new crown pneumonia has given us a deeper understanding of the concept of 'people's health first'"The executive vice president and secretary-general of the Shanghai Pharmaceutical Industry Association, Yi Zhengyu, pointed out that last year's newly revised drug management law for the first time clearly put forward the principle of social governance adhere to risk management, full control, social co-management principle stood up a scientific and strict supervision and management system to comprehensively improve the quality of drugs to ensure the safety, effectiveness and accessibility of drugsFuture Association will continue to work with experts and scholars in the field of medicine to promote the quality of medicines to meet the growing health needs of the people through the development of high-quality differentiated group standardsIn order to better analyze the quality management of the whole life cycle of tumor drugs, Professor Chen Zhidong of the Sixth People's Hospital affiliated with Shanghai Jiaotong University, Professor Huang Zhongyi, Life-long Honorary Director of Clinical Pharmacy and Clinical Pharmacology at Jing'an District Central Hospital, Professor Zhang Jian of Fudan University Affiliated Oncology Hospital, and Professor Prince Tao of the Department of Industrial Engineering of Tsinghua University, introduced the differences between narrow treatment index drug original research and generic drugsExperts refer to the drug dose or blood drug concentration of small differences may lead to serious treatment failure and or adverse drug reactions of the drug its production process and quality of small differences will directly cause safety problems or the absence of efficacy of drug safety and pharmaceutical companies drug quality relationship is closerAlthough special, there is still a lack of a complete catalog of drug varieties in various countries is not completely consistent with the urgent need for drug supervision and management departments to improve the management of normsThe use of consistency evaluation ensures consistency between the quality and efficacy of generic drugs and primary drugs, but despite this, bioequivalent subjects do not represent all clinical patientsInequality of efficacy in clinical practice is commonIf the efficacy of generic drugs and the original drug is not equal may cause the efficacy to enhance or weaken and produce other adverse reactions that affect the treatment of the diseaseShanghai authorities have released the "Narrow Treatment Index Drug Quality Evaluation and Standard-Setting General Technical Requirements" which covers quality management, quality evaluation, stability research and quality standards, etc; Experts stress the need for rigorous quality management throughout the life cycle to ensure that the key quality attributes of the drug are effectively maintained and transmitted throughout the life cycleIt is reported that the "tumor drug treatment standards and quality control" as the theme of the seminar "China Quality Miles" in Beijing, Shanghai, Guangzhou, Nanjing, Hangzhou and other cities in the monthClinical and pharmaceutical experts discuss the safety and quality standards of oncology drugs Complete source: China News Network content display end to determine whether the login ends.
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