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原料药出口欧盟的最新规定及相关国家对策

New Regulations on APIs Export to EU and Countermeasures of Related Countries
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摘要 目的介绍欧盟对进口原料药的最新规定,以帮助国内原料药企业了解并适应原料药出口欧盟的政策新变化。方法详细介绍欧盟有关原料药进口的2011/62/EU最新规定的内容,以及相关原料药出口国药品管理当局的对应策略。结果与结论相关国家的药品监管部门高度重视并积极应对,与欧盟进行沟通与协调,确定了证明文件的签发程序或者主动申请了豁免资格,为持续稳定、扩大原料药出口提供了政策支持,从而也保证了欧盟市场的药品供应。 Objective To help API manufacturers to understand and adapt to the new EU regulations of API export. Methods The new regulations of Directive 2011/62/EU regarding APIs import were introduced in detail, and the corresponding policies made by the relevant exporting countries were compared. Results and Conclusion Competent authorities of related nations paid close attention to the new regulations and responded actively. They either defined the procedure for issuing the written confirmation or initiatively applied for an exemption, thus provided a policy support for API export and guaranteed medicine supply for EU market.
作者 吕修梅 魏强
机构地区 深圳市远邦医药有限公司 杭州赛诺菲民生健康药业有限公司
出处 《中国药事》 CAS 2014年第3期301-303,共3页 Chinese Pharmaceutical Affairs
关键词 原料药出口 欧盟新规定 62号令 GMP APIs （active pharmaceutical ingredients） export EU new regulations Directive 2011/62/EU GMP
分类号 R95 [医药卫生—药学] R954.2 [医药卫生—药学]
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  • 1European Union. Official Journal of the European Union, Directive 2011/62/EU of the European Parliament and the Council of S June2011 [EB/OL]. (2011-07 01) [2013-10- 15 ] http: //eur-lex. europa, eu/LexUriServ/LexUriServ. do? uri=OJ: L: 2011: 174: 0074: 0087: EN: PDF.
  • 2European Union. Template for the "written confirmation" for active substances exported to the European Union for me- dicinal products for human use, in accordance with Article 46h (2) (h) of Directive 2001/83/EC [EB/OL]. (2013- 01-28) [2013 -10-15] http: //ee. europa, eu/health/files/ gmp/2013 _ 01 _ 28 template, pdf.
  • 3European Union. Documentation/information submitted with a request for listing [EB/OL]. (2013-01) [2013-10-15] ht- tp.. //ec. europa, eu/health/files/gmp/2012_10_list. pdf.
  • 4European Union. Commission Implementing Decision of 23 January 2013, on the assessment of a third country's regu- latory framework applicable to active substances of medicinal products for human use and of the respective control and en- forcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council [EB/OL]. (2013 -01-24)[2013-10-15] http: //ee. europa, eu/ health/files/eudralex/vobl/dee _ 2013 _ 51/dec _ 201 S _ 51 _ en. pdf.
  • 5European Union. A List of third countries which have so far requested to be listed, as well as the status of the request [EB/OL]. [2013-10- 15]http://ee. europa, eu/health/hu man-use/quality/index_ en. htm# ias.
  • 6EMA. Compliance with Good Manufacturing Practice [DB/OL]. [ 2013-10-15 ] http: //eudragmdp. ema. europa, eu/inspections/ grnpc/index, do.
  • 7CFDA.国家食品药品监督管理总局关于出口欧盟原料药证明文件有关事项的通知[EB/OL].(2013-05-07)[2013-10-15]http://www.sfda.gov.cn/WS01/CL0844/80444.html.
  • 8CDSCO. Guidance Document for Issue of Written Confirma- tion for Export of API to EU [EB/OL]. (2013 04-10) [2013- 10-15] http: //edsco. nic. in/WCEPS, htm.
  • 9CDSCO. List of Written Confirmation Granted [EB/OL]. [2013-10-15] http: //edseo. nic. in/we, htm.
  • 10European Union. Importation of active substances for medicinal products for human use, Questions and Auswers Version 4. 1[EB/OL]. (2013-04) [2013-10 -15] http://ee. europa, eu/ health/files/gmp/2013_04_12_qa_en, pdf.
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2014年 第3期

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