中药在加拿大注册情况及中药国际监管协调对策建议

Registration status of Traditional Chinese Medicines in Canada and suggestions on the harmonization strategy for international regulatory of TCMs

中药在加拿大一般以天然健康产品类别申报,属于药品范畴。自加拿大卫生部2019年新的《天然健康产品注册申请管理办法》实施以来,我国多个中药如抗疫“三方”转化而来的“清肺排毒颗粒”“宣肺败毒颗粒”等在加拿大注册成功。本文通过检索加拿大已批准天然健康产品数据库(NPHID),以新办法实施以来加拿大批准的31家中国内地产品持证人的402个中药产品文号为研究对象,对其产品分布特点、申请类型、适应证、处方药味、剂型、品种来源等情况进行了分析,并与国内批准的相关品种进行对比,结果显示:加拿大批准的中药品种中,60%为单方制剂,40%为复方制剂。单方制剂中90%以上品种按简易类型申请,以NHPID专论作为注册证据支持其注册,属于I类;复方制剂的90%以传统申请类型为主,大多为国内已上市品种,主要基于《中国药典》、国家药品标准证据支持其有效性、安全性和/或质量,适应证以中医术语表述其传统功效,一般不包括涉及西医表述的严重疾病。基于中药在加拿大注册批准现状,结合加拿大天然健康产品的最新法规和技术要求,提出了国际中药监管协调的思考与建议:在遵循求同存异原则基础上,建立完善政府间的多边或双边中药监管协调机制,充分发挥传统药物国际交流平台作用,进一步推动我国深度参与传统药质量控制、安全性评价等国际规则的制订、协调工作,支持中药国际注册,全方位推进中药监管国际协调。

Traditional Chinese medicines(TCMs)are generally registered as Natural Health Products(NHPs)in Canada,a subcategory of drug.Since the“Natural Health Products Management of Applications Policy”promulgated and implemented in June 2019,many TCMs have been successfully registered in Canada,such as“Qingfei Paidu Granules”(清肺排毒颗粒),“Xuanfei Baidu Granules”(宣肺败毒颗粒)transformed from the“Three prescriptions”for fighting the epidemic,ect..Through searching the Licensed Natural Health Products Database(LNHPD)for last five years,402 approved TCMs in Canada,owned by 31 Chinese mainland product holders,are screened as the research object of this paper.The product distribution characteristics,application types,indications,prescription,dosage forms and the sources of TCMs products,etc.are analyzed in this paper,as well as compared with related TCMs approved in China.The results show that 60%are single-substance preparations and 40%are compound preparations among the TCMs approved in Canada.More than 90%of single-ingredient prescription preparations are applied as compendial type,supported by NHPID monographs as evidence,belonging to Class I;90%of compound preparations are mainly applied as traditional type,most of which are domestically marketed TCMs,mainly based on the“Chinese Pharmacopoeia”and national drug standards tosupport their effectiveness,safety and/or quality,with the indications expressed in TCM terms for their traditional efficacy,generally not including serious diseases described by Western medicine.Based on the current status of registration and approval of TCMs in Canada,combined with the latest regulations and technical requirements for NHPs in Canada,the paper puts forward thoughts and suggestions on the harmonization strategy for TCM international regulatory:establish and improve multilateral or bilateral TCM regulatory harmonization mechanisms between governments based on following the principle of seeking common ground while reserving differences,make full use of the international communication platform for traditional medicines,further promote our country's in-depth participation in the establishment and harmonization of international rules such as TCMs quality control and safety evaluation,ect.,and support the international registration of TCMs,and finally to promote the international harmonization of TCM regulatory in all directions.