ABSTRACT
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.
ABSTRACT
Objective:To put forward relevant policy recommendations for strengthening the quality control of clinical trial drug production in China. Methods:The objective differences of clinical trials and marketing drugs in the production and management as-pects were in-depth analyzed, and the lessons in clinical trial drug production quality supervision and management experience were drawn from the FDA and the European Union EMA. Results and Conclusion:Based on the particularity of clinical trial drug produc-tion management,it is suggested to formulate the administrative rules and technical standards for the quality control of clinical trial drug production and amend relevant laws and regulations timely so as to achieve the purpose of strengthening the quality supervision of drug production in clinical trials.
ABSTRACT
OBJECTIVE:To provide reference for exploring the strategy of promoting TCM formula granules.METHODS:The questionnaire was designed to investigate the cognition and attitude of TCM practitioners from different grades to TCM formula granules in our university,and the investigation data were analyzed statistically.RESULTS:A total of 312 questionnaires were collected and 306 questionnaires were collected with recovery rate of 98.08％.Among them,305 questionnaires were effective with effective rate of 99.67％.46.89％ of interviewed practitioners were found to know and understand about TCM formula granule,52.46％ knew but did not understand;the higher the grade,the higher the proportion of the known and the better understanding (P＜0.05);the cognitive channels included diagnosis and treatment course (69.64％),took by others (65.02％),took by oneself (51.49％).TCM formula granules were easy to take without decoction (95.71％) and easy to carry (87.13％),the advantage of which had high popularity,but there was not much knowledge about other advantages.7.54％ of interviewed practitioners fully appreciated TCM formula granules and 69.18％ recognized them;the higher the grade,the higher the degree of recognition (P＜ 0.05).89.51％ were willing to learn more about TCM formula granules.60.98％ said they would prescribed TCM formula granules in the furure.Among the influential factors for the attitude of the practitioners to TCM formula granules,the three factors with the highest influence were the influence of the teachers,the influence of the patients and their own practice.CONCLUSIONS:The practice of TCM practitioners in our university in Beijing is not ideal for the cognition of TCM formula granules.There is still a great room for improvement in the attitude to TCM formula granules.The teachers and patients are key influential factors for the attitude to TCM formula granules.