RESUMEN
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.
RESUMEN
It has been 4 years since Natural Health Products Regulations(NHPRs)was enforced by Health Canada in January of 2004.In the past time,how will it affect the marketed Traditional Chinese Medicines(TCM) in Canadian market? Recently,The two TCM products Carditionic Pill (Fufang Danshen Diwan)and Chaihu Pill from Tasly have been newly certificated by Health Canada recently.Taking them as examples,this article introduces the current status.opportunities and challenges for the regulation of TCM in Canada.and suggests that the domestic TCM corporations push the product registration as soon as possible.
RESUMEN
The number of people that use Natural Health Products (NHP), not only as a complementary medical treatment, but also for disease prevention and health maintenance, has increased considerably in recent years. Although classified as a food, NHPs can have various pharmacological effects, leading to situations that cannot be ignored by healthcare administrators. However, the level of knowledge and awareness of NHPs are inadequate among healthcare professionals. The Medical Supplement Advisor (MSA) Certification Course that is introduced here is an advanced level course intended for medical professionals only, which examine NHPs, categorized by specific diseases, based on EBM. The contents and arrangement of this course allow clinical physicians and pharmacists to learn and acquire more effectively the knowledge and tools of NHPs and has also been designed with special attention to the clinical application of that knowledge. In order to maximize convenience, the entire course is offered on-line and a CBT system is utilized for the qualification exam. It is essential for healthcare administrators in the future to be able to critically assess information about NHPs and to play a guiding role in health management programs and comprehensive medical care that incorporate Natural Health Products.<br>