Résumé
Under the national policy background of traditional Chinese medicine（TCM）registration review and approval reform， TCM preparations in medical institutions（hereinafter referred to as medical institution preparations） have human use experience， conform to the characteristics of TCM clinical practice， and have advantages in the research and development of innovative Chinese medicines. Therefore， the research and development mode based on clinical experience prescription-medical institution preparations-innovative Chinese medicines has attracted widespread attention from the industry. However， in the process of development and use of medical institution preparations， there are generally clinical problems that restrict their transformation into innovative Chinese medicines， resulting in a relatively weak collection basis of human use experience and insufficient clinical evidence for supporting the research and development of new TCM medicines. In this paper， on the basis of sorting out the supporting regulations and relevant technical requirements of human use experience， and analyzing the clinical problems restricting the transformation of medical institution preparations， it provides suggestions for medical institutions to carry out high-quality research on human use experience of preparations in the process of TCM clinical practice from the aspects of continuously exploring clinical value， improving the construction of information system， focusing on the TCM clinical practice and giving full play to the advantages of discipline cooperation. By realizing the whole life cycle management of medical institution preparations based on three-combination evaluation evidence system， we can promote the transformation of medical institution preparations into innovative Chinese medicines.
Résumé
Traditional Chinese Medicine (TCM) products could be registered as natural health products (NHPs) in Canada. Its registration process could be mainly divided into simple-application, traditional-application and non-traditional application. By analyzingi the TCM registration evidence system and its safety, effectiveness and quality required by different registration categories in Canada, we found that "simple-application" procesure needs to submit evidence based on the parameters of a component in the monograph. As for "traditional application", TCM products need to be used at least 50 years with, traditional material or Pharmacopoeia can be used as evidence; As for non-traditional application, TCM products need to provide evidence according to the disease risk level, and most of them need to provide scientific experiment evidence. Therefore, from the experience of TCM registration evidence system in Canada, the registration of TCM products should pay attention to improve the its classification method, refining its evidence requirements and data types, promoting the formulation of monograph of TCM, realizing the scientific evaluation and rapid review of classic famous prescriptions, and promoting the inheritance and innovative development of TCM in China.
Résumé
With rapid social and economic development in this country,injury has become one of the three major health issues with public concern.To reduce the burden of diseases as disability and medical treatment that caused by injury also became important in public health.Programs related to comprehensive evaluation on disease burden caused by injury and evidence-based strategies on injury-related prevention became substantially important.Our article-“The Disease Burden caused by Injury”,we involved a series of papers based on the systematic databases which focusing on the current status and the change of types of injuries in the Chinese population.Hopefully,it could provide key clues for the development of injury prevention and control programs in the future.
Résumé
With rapid social and economic development in this country,injury has become one of the three major health issues with public concern.To reduce the burden of diseases as disability and medical treatment that caused by injury also became important in public health.Programs related to comprehensive evaluation on disease burden caused by injury and evidence-based strategies on injury-related prevention became substantially important.Our article-“The Disease Burden caused by Injury”,we involved a series of papers based on the systematic databases which focusing on the current status and the change of types of injuries in the Chinese population.Hopefully,it could provide key clues for the development of injury prevention and control programs in the future.