中成药在加拿大的注册情况分析及对我国中药国际注册的启示

通过检索加拿大天然健康产品数据库（LNHPD），对在加拿大成功注册上市的92种中成药的特点及现状进行分析，发现有效注册者所属企业主要集中于北京、广东、天津等中医药发展情况较好的地区；有效注册的中成药包括单味/单一有效成分药64种（69.6%）、复方制剂28种（30.4%），剂型以片剂、胶囊剂为主，具有剂量准确、理化性质...

Analysis on the registration of Chinese patent medicines in Canada and its referantial significance to the international registration of Traditional Chinese Medicines

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.