RESUMO
Because of the unique nature and treatment concept of traditional Chinese medicines (TCMs), TCMs have been respected again since 70s of last century. The regulatory agencies of some developed countries (the FDA, EMA and Health Canada etc) have published new guidance/guidelines/directives in recent years, such as the botanical drug product guidance of the FDA, the evidence for quality of finished natural health products guidance of the Health Canada and the guideline on quality of herbal medicinal products/ traditional herbal medicinal products of the EMA etc. All of the regulatory agencies are willing to scientifically evaluate the herbal medicines and accept it as therapeutic product. This paper analyzed the history of herbal medicine regulation and the similarities and differences of the regulatory requirements of the European Union, the United States and Canada, proposed possible future direction of the international development of Chinese medicine from the perspective of global regulatory affairs.
Assuntos
Humanos , Canadá , Controle de Medicamentos e Entorpecentes , História , União Europeia , Medicina Herbária , História , História do Século XX , História do Século XXI , Fitoterapia , Padrões de Referência , Plantas Medicinais , Química , Estados UnidosRESUMO
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.