欧盟植物药微生物标准制度最新发展及其启示——兼论“一带一路”背景下我国的法律对策
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摘要
目前我国植物药鲜有在欧盟注册成功的重要原因之一,即植物药微生物含量达不到欧盟标准的限量要求。欧盟以其完善的植物药微生物标准制度保证了进出口植物药的品质。相比之下我国微生物标准制度仍存在很多不足。近年来欧盟加快了植物药微生物标准的修订工作。因此考察欧盟植物药微生物相关立法及最新动态,在"一带一路"背景下借鉴欧盟先进做法,完善我国植物药微生物标准制度进而促进我国植物药国际化则显得尤为必要。
Currently,one of reasons for Chinese herbal medicine failure to register in EU is the microbiological standard problem. Perfect microbiological standard system guaranteed the quality of import and export herbal medicine quality.Recently,EU focuses on the revision of microbiological standards system for herbal medicine. It is necessary to study the herbal medicine microbial standard system and its latest development,so as to perfect our herbal medicine microbiological standard system,and to promote the internationalization of Chinese herbal medicine with background of OBOR.
Currently,one of reasons for Chinese herbal medicine failure to register in EU is the microbiological standard problem. Perfect microbiological standard system guaranteed the quality of import and export herbal medicine quality.Recently,EU focuses on the revision of microbiological standards system for herbal medicine. It is necessary to study the herbal medicine microbial standard system and its latest development,so as to perfect our herbal medicine microbiological standard system,and to promote the internationalization of Chinese herbal medicine with background of OBOR.
引文
[1]Pranav Vashith.An update on herb induced chronic kidney diseases[J].International Journal of Research and Development in Pharmacy and Life Sciences,2013(2):429-430.
[2]Ivan Kosalec.Contaminants of Medicinal Herbs and Herbal Products[J].The Journal of Institute for Medical Research and Occupational Health,2009(4):485-501.
[3]刘思齐,等.欧盟药品标准语标准物质管理研究[J].中国药物警戒,2014(11):665-666.
[4]陈健明.微生物技术在中药炮制工艺中的应用现状[J].中国民族民间医药,2016(5):20-21.
[5]涂永前,张庆庆.食品安全国际标准在我国食品安全立法中的地位及其立法完善[J].社会科学研究,2013(3):77-78.
[6]国家发展改革委,外交部,商务部.推动共建丝绸之路经济带和21世纪海上丝绸之路的愿景与行动[M].北京:人民出版社,2015:10.
[7]金立群,林毅夫,等.“一带一路”引领中国——国家顶层战略设计与行动布局[M].北京:中国文史出版社,2015:118.
[8]祁悦,卞鹰.欧盟与中国植物药标准的比较研究[J].时珍国医国药,2009(5):1286-1288.
[9]E·博登海默.法理学:法律哲学与法律方法[M].邓正来,译.北京:中国政法大学出版社,2004:437-438.
(1)European Medicines Agency.Public statement on the risks associated with the use of herbal productcontaining aristolochia species[EB/OL],http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/04/WC500089957.pdf,访问日期:2018-03-09。
(2)European Medicines Agency. Relection paper on microbiological aspects of herbal medicinal productand traditional herbal medicinal products[EB/OL],http://www. ema. europa. eu/docs/en_GB/document_library/Scientific_guideline/2015/06/WC500187592.pdf,访问日期:2018-04-20。
(3)Regulation(EC)No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs,Article 2。
(4)Directive 2004/24/EC of The European parliament and of the council of 31 March 2004,Article 1。
(5)Guideline on Good Agricultural and Collection Practice for Starting Materials of Herbal Origin,Article 2。
(6)Good Manufacturing Practice(GMP)guidelines,Article 5。
(7)Good Manufacturing Practice(GMP)guidelines,Annex 7:Manufacture of Herbal Medicinal Products。
(8)Council of Europe,The Convention on the Elaboration of a European Pharmacopoeia,Article 1。
(9)European Medicines Agency. Relection paper on microbiological aspects of herbal medicinal productand traditional herbal medicinal products[EB/OL],http://www. ema. europa. eu/docs/en_GB/document_library/Scientific_guideline/2015/06/WC500187592.pdf,访问日期:2018-04-22。
[2]Ivan Kosalec.Contaminants of Medicinal Herbs and Herbal Products[J].The Journal of Institute for Medical Research and Occupational Health,2009(4):485-501.
[3]刘思齐,等.欧盟药品标准语标准物质管理研究[J].中国药物警戒,2014(11):665-666.
[4]陈健明.微生物技术在中药炮制工艺中的应用现状[J].中国民族民间医药,2016(5):20-21.
[5]涂永前,张庆庆.食品安全国际标准在我国食品安全立法中的地位及其立法完善[J].社会科学研究,2013(3):77-78.
[6]国家发展改革委,外交部,商务部.推动共建丝绸之路经济带和21世纪海上丝绸之路的愿景与行动[M].北京:人民出版社,2015:10.
[7]金立群,林毅夫,等.“一带一路”引领中国——国家顶层战略设计与行动布局[M].北京:中国文史出版社,2015:118.
[8]祁悦,卞鹰.欧盟与中国植物药标准的比较研究[J].时珍国医国药,2009(5):1286-1288.
[9]E·博登海默.法理学:法律哲学与法律方法[M].邓正来,译.北京:中国政法大学出版社,2004:437-438.
(1)European Medicines Agency.Public statement on the risks associated with the use of herbal productcontaining aristolochia species[EB/OL],http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/04/WC500089957.pdf,访问日期:2018-03-09。
(2)European Medicines Agency. Relection paper on microbiological aspects of herbal medicinal productand traditional herbal medicinal products[EB/OL],http://www. ema. europa. eu/docs/en_GB/document_library/Scientific_guideline/2015/06/WC500187592.pdf,访问日期:2018-04-20。
(3)Regulation(EC)No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs,Article 2。
(4)Directive 2004/24/EC of The European parliament and of the council of 31 March 2004,Article 1。
(5)Guideline on Good Agricultural and Collection Practice for Starting Materials of Herbal Origin,Article 2。
(6)Good Manufacturing Practice(GMP)guidelines,Article 5。
(7)Good Manufacturing Practice(GMP)guidelines,Annex 7:Manufacture of Herbal Medicinal Products。
(8)Council of Europe,The Convention on the Elaboration of a European Pharmacopoeia,Article 1。
(9)European Medicines Agency. Relection paper on microbiological aspects of herbal medicinal productand traditional herbal medicinal products[EB/OL],http://www. ema. europa. eu/docs/en_GB/document_library/Scientific_guideline/2015/06/WC500187592.pdf,访问日期:2018-04-22。