[1]汤依娜,邹文俊,张浩,等.欧盟草药药品质量标准中杂质检测相关要求[J].中国中医药信息杂志,2007,14(8):1-5.
 [J].zhongguo zhongyiyao xinxi zazhi,2007,14(8):1-5.
点击复制

欧盟草药药品质量标准中杂质检测相关要求

参考文献/References:

[1] European Parliament and the Council. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use[J].Official Journal of the European Union,2004,L 136/85-L 136/90.

[2] HMPC.Guideline On Quality Of Herbal Medicinal Products/ Traditional Herbal Medicinal Products[EB10L].http://www.emea. europa.eu,2006-10-01.

[3] HMPC.Guideline On Specifications: Test Procedures And Acceptance Criteria For Herbal Substances, Herbal Preparations And Herbal Medicinal Products/Traditional Herbal Medicinal Products[EB10L].http://www.emea.europa.eu,2006-10-01.

[4] 20408. Heavy metals. Ph Eur[S].5.0,Vol.1,2005.104-107.

[5] 20813 Heavy metals in herbal drugs and fatty oils. Ph Eur[S].5.0,Vol.1,2005.119-120.

[6] 20402. Arsenic. Ph Eur[S].5.0,Vol.1,2005.103.

[7] European Commission. Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs[J].Official Journal of the European Union,2001,L77/1-L 77/13.

[8] BMG.Arzneimittel-Kontaminanten-Empfehlungen-Schwermetalle,(BMG 355-5135)[EB10L].http://www.ctca.de/Aktuelles.aspx,1991-10-17.

[9] 20813 Pesticide Residues.Ph Eur[S].5.0,Vol.1, 2005.218-221.

[10] German Federal Ministry of Food, Agriculture and Consumer Protection. German Maximum Residue Levels Ordinance [EB10L]. http:// www.bmelv.de,1994-09-01.

[11] 1433 Herbal drugs. Ph Eur[S].5.0,Vol.1,2005.572-575.

[12] European Commission. Commission Regulation(EC)No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs[J].Official Journal of the European Union,2006,L 70/12-L 70/34.

[13] German Federal Ministry of Justice.Verordnung über das Verbot der Verwendung von mit Aflatoxinen kontaminierten Stoffen bei der Herstellung von Arzneimitteln[EB].http://www.gesetze-im- internet. de/aflatoxinverbotsv/index.htmL,2000-07-18.

[14] European Commission. Commission Regulation(EC)No 123/2005 of 26 January 2005 amending Regulation(EC)No 466/2001 as regards ochratoxin A[J].Official Journal of the European Union,2001,L 25/3-L 25/5.

[15] European Commission.Commission Regulation (EC)No 1425/2003 of 11 August 2003 amending Regulation (EC)No 466/2001 as regards patulin[J].Official Journal of the European Union,2003,L 203/1-L 203/3.

[16] HMPC.Reflection Paper on the use of Fumigants,(Doc. Ref. EMEA/ HMPC/125562/2006)[EB10L].http://www.emea.europa.eu,2006-10-26.

[17] 20612 Microbiological Examination Of Non-Sterile Products (Total Viable Aerobic Count).Ph Eur[S].5.0,Vol.1,2005:154-156.

[18] 20613 Microbiological Examination Of Non-Sterile Products (Test For Specified Micro-Organisms).Ph Eur[S].5.0,Vol.1, 2005. 156-161.

[19] 50104 Microbiological Quality Of Pharmaceutical Preparations. Ph Eur[S].5.0,Vol.1,2005.449.

[20] EMEA.Note for guidance on impurities in new drug products. (CPMP/ICH/2738/99)[EB10L].http://www.emea.europa.eu,2006-06.

[21] 20424 Identification And Control Of Residual Solvents. Ph Eur[S].5.0,Vol.1, 2005.113-118.

[22] 50400 Residual Solvents. Ph Eur[S].5.0,Vol.1,2005.507-515.

相似文献/References:

[1]汤依娜,邹文俊,刘忠荣,等.欧盟草药药品管理机构及其职能[J].中国中医药信息杂志,2006,13(6):1.
[2]邹文俊,刘忠荣,叶祖光.欧盟药品与传统草药药品注册通用技术文件概述[J].中国中医药信息杂志,2005,12(9):1.

备注/Memo

基金项目:科技部2006年国际科技合作与交流重点项目(2006DFB33420)

更新日期/Last Update: