ABSTRACT
In leading the high-quality development of Chinese medicine preparations, it is an important link to formulate the scientific, reasonable, and feasible guidelines for the change of Chinese medicines in accordance with the change characteristics and principles of the Chinese medicines is an important work to promote the Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines was formed by a broad consensus based on the characteristics and research results of the pharmaceutical changes in Traditional Chinese Medicines(TCM)with the principles of science and risk management. This guideline has clarified the basic principles and requirements for the evaluation of changes in TCM, specified the research and verification work of common change scenarios, defined the boundaries of changes in TCM, and proposed to encourage the use of new technologies, new methods, and new excipients that meet product characteristics. It will definitely promote the quality improvement and the secondary development of TCM. In this article, the revision background and main content of the guideline were introduced, and the main features of the Guideline were analyzed, in order to provide references for the industry.
Subject(s)
Consensus , Drug Compounding , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Pharmaceutical Preparations , Quality ImprovementABSTRACT
Influenza virus infection is a respiratory infectious disease. The World Health Organization (WHO) estimated that seasonal influenza epidemics have caused an annual 3 to 5 million severe cases, and 290 000 to 650 000 deaths globally. Seasonal influenza vaccination is the most effective way to prevent influenza virus infection and complications from infection. Currently, China has licensed trivalent inactivated influenza vaccine (IIV3) and quadrivalent inactivated influenza vaccine (IIV4). In 2018, the Chinese Center for Disease Control and Prevention issued the "Technical Guidelines for Seasonal Influenza Vaccination in China (2018-2019)" ( "Guide 2018" for short). To strengthen the technical guidance for prevention and control of influenza and operational research on influenza vaccination in China, the National Immunization Advisory Committee (NIAC) Influenza Vaccination Technical Working Group (TWG), updated the 2018 technical guidelines and compiled the "Technical guidelines for seasonal influenza vaccination in China (2019-2020)" . The main updates in this version include the following: First, new research evidences especially studies of China, including disease burden, effectiveness, Vaccine-avoidable disease burden, vaccine safety monitoring, and cost-effectiveness and cost-benefit. Second, policies and measures for influenza prevention and control issued by National Health Commission (PRC) in the past year. Thirdly, new type seasonal influenza vaccine licensed and issued in 2019-2020 in China. Fourth, northern hemisphere influenza vaccination composition for the 2019-2020 season which included trivalent and quadrivalent influenza vaccine. The recommendations described in this report include the following: Points of Vaccination clinics (PoVs) should provide influenza vaccination to all persons aged 6 months and above who are willing to be vaccinated and do not have contraindications. No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one licensed, recommended, and appropriate product is available. To decrease the risk of severe infections and complications due to influenza virus infection among high risk groups, the recommendations prioritize seasonal influenza vaccination for children aged 6-59 months, adults ≥60 years of age, persons with specific chronic diseases, healthcare workers, the family members and caregivers of infants <6 months of age, and pregnant women or women who plan to become pregnant during the influenza season. Children aged 6 months through 8 years require 2 doses of influenza vaccine administered a minimum of 4 weeks apart during their first season of vaccination for optimal protection. If they were vaccinated in 2018-2019 influenza season or a prior season, 1 dose is recommended. People more than 8 years old require 1 dose of influenza vaccine. It is recommended that people receive their influenza vaccination by the end of October. Influenza vaccination should be offered as soon as the vaccination is available. For the people unable to be vaccinated before the end of October, influenza vaccination will continue to be offered for the whole season. Influenza vaccine is also recommended for use in pregnant women during any trimester. These guidelines are intended for use by staff members of the Centers for Disease Control and Prevention at all levels who work on influenza control and prevention, PoVs staff members, healthcare workers from the departments of pediatrics, internal medicine, and infectious diseases, and staff members of maternity and child care institutions at all levels. These guidelines will be updated periodically as new evidence becomes available.
ABSTRACT
Human adenovirus (HAdV) is one of the common pathogens causing human respiratory infections and HAdV infection can result in a variety of diseases. In recent years, outbreaks of HAdV infection have been detected from time to time in China and clustered severe cases have been reported in some regions. This technical guideline has been timely developed to provide technical support on the control and prevention of HAdV respiratory infections. It provides an overview of etiology, epidemiology, clinical manifestations, and treatment principles of HAdV infection, determines the definitions of laboratory-confirmed cases, clinically diagnosed cases, severe and critically severe HAdV pneumonia cases. Then the workflow of case detecting and reporting, and the outbreak epidemic disposal has been formulated. Finally, the control and prevention measures in places at high risk for HAdV transmission and individual preventive measures also has been introduced.
ABSTRACT
Human adenovirus (HAdV) is one of the common pathogens causing human respiratory infections and HAdV infection can result in a variety of diseases. In recent years, outbreaks of HAdV infection have been detected from time to time in China and clustered severe cases have been reported in some regions. This technical guideline has been timely developed to provide technical support on the control and prevention of HAdV respiratory infections. It provides an overview of etiology, epidemiology, clinical manifestations, and treatment principles of HAdV infection, determines the definitions of laboratory-confirmed cases, clinically diagnosed cases, severe and critically severe HAdV pneumonia cases. Then the workflow of case detecting and reporting, and the outbreak epidemic disposal has been formulated. Finally, the control and prevention measures in places at high risk for HAdV transmission and individual preventive measures also has been introduced.