ABSTRACT
Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,were proposed by Professor ZHANG Bing from Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,and underwent centralized management by Chinese Association of Chinese Medicine. They were officially released on July 23 and implemented on July 31,2021. The series of group standards consist of six sections,including general principles,adverse drug events,contraindications,precautions,application for special populations,and warnings. The section of general principles is comprised of holistic and programmatic expressions,which explain the general technical requirements for revising the marketed Chinese patent medicine instructions. The other five sections focus on information collection,screening,transformation,and illustration of specific items,forming a standardized revision technical process. This series of standards is the result of multiple rounds of research and the suggestions of more than 200 experts in different professional fields of " medicine-pharmacy-management-law-enterprise" have been gathered therein to reach a consensus. With the purposes of establishing standardized technical specifications for the revision of safety information in the marketed Chinese patent medicine instructions,guiding marketing authorization holders in revising the instructions,filling the gaps in the research of Chinese patent medicine instructions,promoting the deve-lopment of pharmaceutical care and academic research,and encouraging the rational and safe medication of Chinese patent medicine,the series of group standards is of great significance.
Subject(s)
Humans , China , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional , Nonprescription Drugs/adverse effects , PharmacovigilanceABSTRACT
Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public. The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs. In the drug life cycle,marketing authorization holders( MAHs) need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication. At present,revising instructions is an important measure to control drug risks. In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as " unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine. Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of " Healthy China".
Subject(s)
Humans , China , Drug-Related Side Effects and Adverse Reactions , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional , Nonprescription Drugs/adverse effects , Reference StandardsABSTRACT
This standard specifies the terms and definitions, processes, components, information systems and information summary, analysis and utilization of health management of major chronic and non-communicable diseases (chronic diseases). It is suitable for medical and health service institutions, health examination institutions and health management-related enterprises to carry out health management services for individuals with major chronic diseases such as cardiovascular diseases, diabetes, cancer, chronic respiratory diseases and so on.
ABSTRACT
This standard stipulates the principles, institutional requirements, inspection items, service modes, data management and utilization requirements for carrying out the health check-up for rural residents. It is applicable to the standardized management of the health check-up for rural residents aged 15 years old and above under the relevant national laws and regulations.
ABSTRACT
With the acceleration of the population aging in China, the health problems and the demands of health services such as health check-up for rural residents should attract the attention of the whole society. The group standard entitled Health check-up guide for rural residents (T/CHAA 005-2019), was written by experienced researchers from Chinese Center for Disease Control and Prevention and other professional institutes coordinated by Chinese Health Association. The standard aims to establish a service model that takes health information collection as a means, health risk assessment, health risk intervention and information services as the core, improving the health of rural residents as the target.
ABSTRACT
This article illustrates that health management, as one of the tools of health service, plays an important role in the control and treatment of chronic diseases as well as the history of health management development in China. It was pointed out that currently the concept of health management is not well established in China and the practice of health management in the Chinese market is quite in a mess. Therefore, there is an urgent need for the standardization of health management practice. The China Health Management Association released an organizational standard entitled "Standard for Chronic Disease Health Management" in November, 2019. It is comprehensive, science-based, easy to use and fit into the Chinese situation and it is expected that it will facilitate the development of health management in China.
ABSTRACT
Precision medicine became the key strategy in development priority of science and technology in China.The large population-based cohorts become valuable resources in preventing and treating major diseases in the population,which can contribute scientific evidence for personalized treatment and precise prevention.The fundamental question of the achievements above,therefore,is how to construct a large population-based cohort in a standardized way.The Chinese Preventive Medicine Association co-ordinated experienced researchers from Peking University and other well-known institutes to write up two group standards Technical specification of data processing for large population-based cohort study (T/CPMA 001-2018) and Technical specification of data security for large population-based cohort study (T/CPMA 002-2018),on data management.The standards are drafted with principles of emphasizing their scientific,normative,feasible,and generalizable nature.In these two standards,the key principles are proposed,and technical specifications are recommended in data standardization,cleansing,quality control,data integration,data privacy protection,and database security and stability management in large cohort studies.The standards aim to guide the large population-based cohorts that have been or intended to be established in China,including national cohorts,regional population cohorts,and special population cohorts,hence,to improve domestic scientific research level and the international influence,and to support decision-making and practice of disease prevention and control.
ABSTRACT
Long-term follow-up for end point is an extremely important and arduous task in large population-based cohort studies, which is also the key to the success of large cohort studies. Thus, the fundamental question of the achievements above is how to construct a large population- based cohort in a standardized way. The Chinese Preventive Medicine Association coordinated experienced researchers from Zhejiang Provincial Center for Disease Control and Prevention and other professional institutes to write up the group standard entitled Technical specification of long-term follow-up for end point in large population-based cohort study (T/CPMA 002-2019). The standard is drafted with principles of emphasizing the scientific, normative, applicability, and feasible nature. This group standard recommended the follow-up target population, time, content, methods, quality control, and indicators assessment. The standard aims to guide the large population-based cohorts that have been or intended to be established in China, including national cohorts, regional population cohorts, and special population cohorts, hence, to improve domestic scientific research level and the international influence, and to support decision-making and practice of disease prevention and control.
ABSTRACT
Large population-based cohort study is an important resource for population disease prevention and control, the results of which provide scientific basis for individualized treatment and precise prevention, and it is also the key strategic content of precision medicine. The Chinese Preventive Medicine Association coordinated experienced researchers from the Chinese Academy of Medical Sciences and other professional institutes to write up the group standard entitled Technical specification of management for field investigation in large population-based cohort study (T/CPMA 001-2019). Based on the research of large population-based cohort study in China and the principle of scientific, normative, applicable, and feasible, the standard proposed six aspects of management requirements including institutional arrangement, personnel composition, equipment, materials, documents and finance, as well as the basic requirements of the on-site investigation, the requirements of each position and the overall quality control requirements, etc.. The standard aims to guide the large population-based cohorts that have been or intended to be established in China, including national cohorts, regional population cohorts, and special population cohorts, hence to improve scientific research level, accelerate scientific research output and provide localization basis for disease prevention and control in China.
ABSTRACT
Yersiniosis is one of the "other infectious diarrhea" of the notifiable infectious diseases and also an important food-borne disease. However, it lacked the basis or standard for diagnosis. The Chinese Preventive Medicine Association coordinated experienced researchers from National Institute for Communicable Disease Control and Prevention, China CDC and other institutes to produce the group standard entitled "Diagnosis of Yersiniosis" (T/CPMA 005-2019). Based on the principle of "legality, scientificity, advancement, and feasibility" , the standard gives a clear definition for Yerisiniosis, stipulates diagnosis basis, principles and main differential diagnosis and provides two informative appendixes for epidemiological and clinical characteristics and a normative appendix for laboratory detection. The standard provides accurate basis and methods of Yersiniosis diagnosis for hospitals and CDCs at all levels in China. It will solve the problems that Yersiniosis cannot be clearly diagnosed for clinical cases and in the outbreaks.
ABSTRACT
Precision medicine became the key strategy in development priority of science and technology in China.The large population-based cohorts become valuable resources in preventing and treating major diseases in the population,which can contribute scientific evidence for personalized treatment and precise prevention.The fundamental question of the achievements above,therefore,is how to construct a large population-based cohort in a standardized way.The Chinese Preventive Medicine Association co-ordinated experienced researchers from Peking University and other well-known institutes to write up two group standards Technical specification of data processing for large population-based cohort study (T/CPMA 001-2018) and Technical specification of data security for large population-based cohort study (T/CPMA 002-2018),on data management.The standards are drafted with principles of emphasizing their scientific,normative,feasible,and generalizable nature.In these two standards,the key principles are proposed,and technical specifications are recommended in data standardization,cleansing,quality control,data integration,data privacy protection,and database security and stability management in large cohort studies.The standards aim to guide the large population-based cohorts that have been or intended to be established in China,including national cohorts,regional population cohorts,and special population cohorts,hence,to improve domestic scientific research level and the international influence,and to support decision-making and practice of disease prevention and control.