1.Review on the registration of herbal drugs in north America and Europe
Yong TAN ; Bo WEN ; Jiayin WEI ; Xiaoyu FENG ; Yuwen XIA ; Lin LIN ; Longhui YANG
International Journal of Traditional Chinese Medicine 2024;46(2):162-167
International registration of herbal drugs is a necessary prerequisite for the internationalization of Chinese materia medica. North America and European Union occupy an important position in the world herbal drugs market, and their drug administration and quality supervision requirements are relatively complete and progressiveness. By summarizing the definition of herbal drugs in North America and European Union, combing and interpreting the relevant laws, regulations and policy documents, this article constructed the registration path of herbal drugs, and discussed the current status of market registration of herbal drugs in North America and European Union based on the examples of successful marketing of herbal drugs under current application and approval in overseas markets. This article believed that in the future, an internationally matched TCM quality standard evidence system should be built, clinical trials of TCM products in line with international standards should be carried out, standards that are the same or higher than international mainstream GMP should be developed, the registration path of TCM compounds should be explored, and professionals to establish an international registration application team should be recruited to provide theoretical and practical support for China's overseas registration of Chinese TCM products, promote TCM products to enter the world mainstream market, and achieve high-quality development of TCM internationalization.
2.Discussion on the Social Return after the Outbreak of COVID -19
Shouping GONG ; U Jianrui LY ; Honghong PEI ; Huiyun YANG ; Erdi XU ; Rong WANG ; Ruizhi WANG ; Huqing WANG ; Longhui FU
Chinese Medical Ethics 2024;35(5):568-572
After COVID -19, patients, medical workers and the whole society in COVID -19 were faced with the challenge of how to quickly return to normal life. Patients cured in COVID -19 would face mental or psychological barriers, or be discriminated against, or face problems such as overweight of local epidemic prevention policies. The front-line medical personnel experienced job burnout and a variety of mental and psychological disorders, with some even developing physical symptoms. During the epidemic, ordinary people were in a state of psychological stress, education, production and economic activities were affected, and the incidence of mental or psychological disorders increases. It was necessary to provide COVID -19 patients with mental health monitoring and counseling. Give professional guidance to front-line medical staff, arrange rotation reasonably, and pay attention to their mental health status. Local governments should strictly implement the national epidemic prevention system, formulate epidemic prevention policies with humanistic care, actively publicize epidemic related knowledge and safeguard the rights and interests of the people.
3.Research Strategy on the Standard Route of Overseas Registration of Traditional Chinese Medicine Formulations
Lin LIN ; Yong TAN ; Bo WEN ; Jiayin WEI ; Xiaoyu FENG ; Xiangpeng WANG ; Yuwen XIA ; Longhui YANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(3):557-563
Objective To explore the ideas,methods and pathways for the registration of Chinese medicine prescriptions in overseas countries,to form a strategy for overseas registration of Chinese medicine,and to provide technical support and reference for China's Chinese medicine prescriptions to go abroad.Methods Five representative countries were selected to form corresponding expert teams and exchange platforms for international cooperation.The laws,regulations,rules,standards,specifications and technical guidance documents related to Chinese medicine prescription preparations of the target countries were used as pathway research materials,and the documents were translated directly,naturalized,proofread and diagrammed,and a problem-oriented mechanism for consultation with domestic and international experts was established to form a pathway for overseas registration of Chinese medicine prescription preparations.Results The path for standardization of overseas registration of Chinese medicines was clarified,and the detailed registration paths and corresponding work strategies of Chinese medicines in five countries were formulated with flow charts,tables and explanatory texts.Conclusion By developing standardized registration pathways for traditional Chinese medicine in target countries,reference can be provided for the internationalization of Chinese herbal formula preparations.
4.The perception and feeling of nursing staff in neonatal palliative care: a Meta-synthesis of qualitative research
Longhui XU ; Guodong YANG ; Xiaoxuan HAN ; Renxiu WANG ; Xiao CONG ; Cuiping XU
Chinese Journal of Practical Nursing 2024;40(33):2618-2625
Objective:To systematically evaluate qualitative studies on the perceptions and feelings of nursing staffs implementing neonatal palliative care, aiming to provide insights for advancing clinical practice in China.Methods:The databases including China National Knowledge Infrastructure, Wanfang, VIP, Chinese Biomedical Literature Database, PubMed, CINAHL, Embase, Cochrane Library, Web of Science, and PsycINFO were included to retrieve the literature on the perceptions and feelings of nursing staffs from inception until March 28, 2024. The literature quality was assessed utilizing the Joanna Briggs Institute Australian Centre for Evidence-Based Health Care Quality Assessment Criteria for Qualitative Research (2016), and the findings were synthesized through Meta-integration techniques.Results:A total of 12 studies were included, yielding 46 themes were extracted; 8 categories were summarized and 3 synthesis results were obtained: nursing staffs experience both negative and positive aspects, the real-life challenges faced by nursing staffs in implementing neonatal palliative care, and the practical experiences and needs of nursing staffs regarding neonatal palliative care.Conclusions:It is crucial to continually address nursing staffs′ negative emotions and tackle challenges related to staffing, training, communication, and ethical dilemmas to ensure appropriate end-of-life symptom management in neonatal palliative care.
5.Requirements and thinking on quality management of Natural Health Products in Canada
Jiayin WEI ; Yong TAN ; Longhui YANG ; Lin LIN ; Bo WEN ; Xiaoyu FENG ; Xiangpeng WANG ; Jiani TAN ; Yuwen XIA
International Journal of Traditional Chinese Medicine 2023;45(11):1360-1365
Introduces the regulatory requirements of the Natural and Over-the-Counter Health Products Administration on the quality of natural health products, and adopts the literature research method to translate and interpret Health Canada's "Guidelines for the Quality of Natural Health Products" on the quality management and quality control of natural health products. Policy documents, from the perspective of stakeholders, provide requirements for the detection methods and standards of natural health products, such as characterization, identification experiments, component content, pollutants and impurity content detection, etc. To achieve natural health Quality management and quality control in the whole process of product production. Familiar with and understand the requirements for the quality management of natural health products in Canada will help to promote the legal and compliant management of product quality in the production process of Traditional Chinese Medicine (TCM) products after registration in Canada, and promote the production and sustainable development of TCM products. At the same time, it provides a reference for further improving my country's drug quality management system normative system documents, and assists the effective connection between the registration-related standards of Chinese patent medicines and international standards.
6.Association between MPV,PDW,PCT and Cardiac Function in Patients with Pulmonary Hypertension
Yan QIU ; Yinli WANG ; Mengmeng YANG ; Liangmin GUO ; Longhui YUAN
Journal of Kunming Medical University 2023;44(12):121-126
Objective To study the association between mean platelet volume(MPV),platelet distribution width(PDW)and procalcitonin(PCT)and cardiac function in patients with pulmonary hypertension(PH)and their diagnostic value on heart failure.Methods 103 patients with PH(PH group)in the 3rd People's Hospital of Chengdu from October 2021 to October 2022 and 103 healthy subjects with physical examination(control group)were selected as study subjects.Fasting peripheral venous blood was collected on the 1st day of admission and MPV,PDW and PCT were detected.The left ventricular ejection fraction(LVEF)was measured and the cardiac function was evaluated by New York Heart Association(NYHA)grading criteria.The patients with PH were divided into failure group and non-failure group according to the diagnosis results of heart failure.The relations of MPV,PDW and PCT with cardiac function in patients with PH and the diagnostic value on heart failure were analyzed.Results The levels of MPV,PDW,and PCT were all higher in the experimental group compared to the control group,while the LVEF was lower,and these differences were statistically significant(P<0.05);as the NYHA classification increased,the levels of MPV,PDW,and PCT showed an increasing trend,while LVEF showed a decreasing trend,and the differences between the groups were statistically significant(P<0.05);in the heart failure group n = 65,the levels of MPV,PDW,and PCT were higher compared to the non-heart failure group n = 38,while LVEF was lower,and these differences were statistically significant(P<0.05).The levels of MPV,PDW,and PCT werr signifi-cantly positively correlated with NYHA functional classification and LVEF(P<0.05).The levels of MPV,PDW,and PCT had good reference value for the diagnosis of heart failure in PH patients,with AUC values of 0.816,0.897,and 0.825 respectively,and the combined diagnostic AUC is 0.952,which wass statistically different from the application of the three indicators alone(P<0.05).Conclusion RDW,PDW and PCT are closely related to cardiac function in patients with PH,and can provide reference information for diagnosis and treatment of heart failure in patients with PH.
7.Analysis of simplified registration of traditional herbal medicinal products in European Union
Huimin HU ; Longhui YANG ; Yong TAN ; Dongmei GUO ; Zixu WANG ; Jing'an BAI ; Jie LIN
International Journal of Traditional Chinese Medicine 2022;44(1):6-11
Europe occupies an important position in the world herbal medicine market. The registration of Traditional Chinese Medicine (TCM) in EU is of great significance to the internationalization of TCM. The European Medicines Agency (EMA) has designed a relatively complete management system and regulatory guidelines for the registration and supervision of herbal medicinal products. The promulgation of the DIRECTIVE 2004/24/EC (2004 / 24 / EC) indicates that TCM could enter the EU market through simplified registration. Based on the registration conditions, registration authority and document guideines of Traditional Herbal Medicinal Products (THMPs) in EU, this paper analyzes the application requirements of simple registration of traditional herbal products in EU, and provides suggestions for the simplified registration of TCM in EU according to the registration requirements of medicinal history, quality requirements and application data format.
8.Analysis on the registration of Chinese patent medicines in Canada and its referantial significance to the international registration of Traditional Chinese Medicines
Shiyu ZHU ; Longhui YANG ; Yong TAN ; Zhanquan WEN ; Lidan ZHONG ; Zixu WANG ; Jing'an BAI ; Jie LIN ; Huimin HU
International Journal of Traditional Chinese Medicine 2022;44(2):126-131
By searching for the Canadian Licensed Natural Health Products Database, (LNHPD), this paper analyzed the characteristics and current status of 92 Chinese patent medicines successfully registered and listed in Canada, and found that the enterprises of successfully registered enterprises are mainly located in areas with better development condition of Traditional Chinese Medicine (TCM) such as Beijing, Guangdong and Tianjin; The successfully registered Chinese patent medicines include 64 kinds of single medicine or medicine with single active ingredient (69.6%) and 28 kinds of compound medicine (30.4%), the forms of the dosage are mainly tablets and capsules, which have the characteristics of accuracy in dosage and stable physicochemical properties. There are also granules, solutions, powders and other dosage forms, which can be preserved for a long time and have low requirements on technic and environment. These Chinese patent medicines are mainly used to treat respiratory and circulatory system diseases, some are used to treat urogenital and digestive system diseases, and few are used to treat difficuilt diseases like tumors, diabetes. There are some other health care products. It is suggested to strengthen the connection between domestic standards of TCM registration and international standards, and promote the scientific and technological capacity of relevant enterprises, and encourage enterprises to strengthen international registration of advantageous products, so as to accelerate the speed of international development of TCM in China.
9.Analysis of Traditional Chinese Medicine regulation in Canada
Jie LIN ; Longhui YANG ; Yong TAN ; Dongmei GUO ; Lidan ZHONG ; Zixu WANG ; Jing'an BAI ; Zhe YU ; Bo WEN
International Journal of Traditional Chinese Medicine 2022;44(2):132-137
This paper analyzes the laws, regulations and concre measures of Traditional Chinese Medicine (TCM) in Canada, so as to provide reference for TCM products to enter Canada, and for the establishment of TCM regulation system and the improvement of its detailed rules in China. The regulation of TCM in Canadian, on the one hand, supervision is to provide guidance for the protection of consumers' rights and interests, including the guidance of rational drug use and rational purchase for consumers; on the other hand, it is to supervise enterprises, including the safety, effectiveness and quality certification of TCM products, labeling and packaging requirements, as well as the site certification of product manufacturing, packaging, labeling and import. The Ministry of health of Canada takes evidence as the core of evaluation, and ensures the safe and effective use of TCM products in Canada through product and site licensing evaluation. In the supervision of TCM, relevant departments in China should further strengthen the protection of consumers' drug rights and interests, strengthen the construction of TCM registration evidence system, and pay attention to the risk management of drug production quality.
10.Introduction and analysis of the registration process of Traditional Chinese Medicine as a natural health product in Canada
Huimin HU ; Longhui YANG ; Yong TAN ; Dongmei GUO ; Yuanchun MA ; Zixu WANG ; Jing'an BAI ; Zhe YU ; Bo WEN
International Journal of Traditional Chinese Medicine 2022;44(3):246-250
At present, the registration process of Traditional Chinese Medicine (TCM) in Canada is refering to the requirements of Natural Health Products (NHPs). In terms of registration material, both NHPs and TCM include plants, animals and minerals with medicinal components, but the fundamental difference between them is that TCM is guided by the basic theory of TCM. As for the registration classification of TCM in Canada, first of all, judge whether the product to be applied for is NHPs; Secondly, we should clarify the types and ways of registration, mainly including simple application, traditional application and non-traditional application, and provide application forms, label texts, summary reports, evidence, animal tissue forms, finished product specifications and other materials according to different requirements. At present, the successful registration experience of TCM products in Canada mainly mainly includes applying for superior varieties, selecting appropriate application channels, communicating with local health management units and providing sufficient scientific evidence and good clinical application records. The regulations on the registration of NHPs in Canada have not fully considered the particularity of TCM and the registration of TCM products is still facing some difficulties. In the future, we can learn from the registration process and requirements of the Health Canada, promote the interconnection and mutual recognition of the Pharmacopoeia of the People's Republic of China and the NNHPD monographs in Canada, reduce the obstacles to the local application for registration of TCM, and promote the further improvement of the international standards of TCM.

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