CAJ | 학술논문

自2004年1月加拿大卫生部正式颁布实施<天然健康产品管理法规>以来,已有近4年的时间.在这4年里,<法规>的实施对中药进入加拿大市场产生了什么样的影响?本文以天津天士力集团的复方丹参滴丸等两个中药品种作为传统药在加拿大的成功申请并获得产品证书为例,通过简述加拿大卫生部对复方中药审评的技术要求和近几年的一些变化,阐述了加拿大卫生部对中约作为治疗性产晶进行管理的明确态度,提出了应塔快组织国内有关力量,积极开展中药向加拿大申请的紧迫性和重要性.
자2004년1월가나대위생부정식반포실시<천연건강산품관리법규>이래,이유근4년적시간.재저4년리,<법규>적실시대중약진입가나대시장산생료십요양적영향?본문이천진천사력집단적복방단삼적환등량개중약품충작위전통약재가나대적성공신청병획득산품증서위례,통과간술가나대위생부대복방중약심평적기술요구화근궤년적일사변화,천술료가나대위생부대중약작위치료성산정진행관리적명학태도,제출료응탑쾌조직국내유관역량,적겁개전중약향가나대신청적긴박성화중요성.
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.