20151221 EP问答1-10

01 How are the monographs selected forinclusion in the European Pharmacopoeia? 各论是如何选定进入EP的？

The European Pharmacopoeia Commissiondecides on a work programme on the basis of proposals from nationalpharmacopoeia authorities, groups of experts and on the basis of requestsreceived by the secretariat. The aim is to include monographs on all substancesused significantly in Europe.

欧洲药典委员会采用工作计划，根据国家药监局、专家组的建议，以及秘书委员会收到的申请来决定。其目的是要在各论中包括在欧洲大量使用的所有物质。

Monograph proposals sent bymanufacturers willing to assist in the preparation of a monograph by providingdata and samples for approved products and by testing the draft monograph arepreferred.

如果生产商提交各论提议，并愿意协助起草各论，提供已批准药品的数据和样品，测试各论草案，则会优先考虑。

02 How can I submit a draft monographfor inclusion in the European Pharmacopoeia?  我如何提交一份各论草案，建议将其增加在EP中呢？

You can submit draft monographs to yournational pharmacopoeia authority and in some instances to the EDQM. For yoursubmission to qualify for consideration, an active substance or excipient mustbe used in an approved medicinal product in several European PharmacopoeiaMember States.

你可以将各论草案提交给你的国家药监机构，有时可以提交给EDQM。为了让你提交的草案能获得通过，该原料药或辅料必须是用于几个欧洲药典成员国已批准上市药品中的品种。

In submitting a monograph you should:

在提交一份各论草案时，你应该：

-     indicate the countries where thesubstance is used in approved medicines; and

-     指明物质在哪个国家用于已批准的药品，以及

-     state your willingness to provide dataand samples (you shall be prepared to co-operate with the EDQM by providingdata and samples).

-     说明你愿意提供数据和样品（你应该准备好配合EDQM提供数据和样品）

Further information is available uponrequest. Where necessary, data is treated in a confidential manner.

如果你索取将可以获得更多信息。必要时，数据会以保密方式来处理。

The final decision on whether themonograph will be added to the Ph. Eur. work programme will be taken by the Ph.Eur. Commission.

你的草案是否最终被增加进欧洲药典工作计划的决策是由欧洲药典委员会来决定的。

03 How can I propose a revision of amonograph?  我如何才能提议对药典各论进行修订呢？

Proposals to revise monographs must bebacked up by sufficient data. Preferably contact your National PharmacopoeiaAuthority. For a list of national authorities, see ‘National Authorities inEurope’ under the ‘Links’ section.Otherwise, you can send your proposal to the EDQM via the link below.

修订各论的提议要用充分的数据来支持，最好联系你的国家药典机构。国家药监机构参见上述链接下的“欧洲国家药监机构”，你也可以将你的提议通过以下链接提交EDQM。

04. How long does the revision of amonograph take?  各论修订要多长时间？

Editing errors can be corrected within afew months. Minor revisions take about 1 year. Major revisions take at least 2years.

编辑性错误在几个月内即可纠正。小的修订要1年时间，大的修订至少2年。

05. How can I find out why revisionswere made to the European Pharmacopoeia? 我怎么能知道欧洲药典修订的原因呢？

Major revisions are published in Pharmeuropawith a “NOTE…” giving the background for the changes. After publication, theinformation is included in the Knowledge Database. View the ‘History’ field.

大的修订会在药典里公布，同时有一个“注意……”给出变更的背景。在公布后，相关信息会包括在上述链接“知识数据库”里。参见“历史”栏目。

06. How can I comment on a textpublished in Pharmeuropa? 我如何能给药典在线公布的内容提出建议呢？

You can submit your comments either viayour National Pharmacopoeia Authority or via the Ph. Eur. Secretariat (via theHelpdesk if outside Europe). In any case, please submit comments before thespecified deadline. Please refer to the “How to comment” noticeavailable at the top of each published text.

你可以通过你的国家药典机构或欧洲药典委员会（如果不在欧洲境内通过帮助桌面）提出建议。不管怎样，请在指定时限前提交建议。参见每份公布征求意见内容页面顶端的“如何提出建议”链接里的内容。

07. If I analyse a substance accordingto a Ph. Eur. monograph, do I also need to demonstrate compliance with thenational monograph? 如果我按照欧洲药典各论对物质进行了分析，我还需要证明符合国家各论吗？

No. The European Pharmacopoeiamonographs are valid in all the Member States of the European Pharmacopoeia.

不需要。欧洲药典各论在欧洲药典所有成员国内均有效。

08. If I analyse a substance accordingto a national monograph, do I also need to demonstrate compliance with a Ph.Eur. monograph? 如果我按照一个国家各论对物质进行了分析，我还需要证明其符合欧洲药典各论吗？

This question should be addressed to thecompetent authorities of the countries involved. As a minimum, for Ph. Eur.member states, you should ensure that the European Pharmacopoeia monograph hasbeen transposed into the national pharmacopoeia by the specified implementationdate

这个问题需要向相关国家的管理机构咨询。最低要求，对于欧洲药典成员国，你必须保证欧洲药典各论已在指定的实施日期引入了国家药典。

09. How can I find the reference number,exact name or status of a European Pharmacopoeia monograph for a particularsubstance? 我如何能找到欧洲药典指定物质的各论索引号、准确名称或状态？

In addition to the EuropeanPharmacopoeia, you can verify this information in the Knowledge Database

除了在欧洲药典里查找外，你还可以在“知识数据库”确认此信息。

10. How can I know if a monograph ispresent in the Ph. Eur.? 我如何知道一个各论是否包括在欧洲药典里呢？

The Knowledge database provides information on the currentstate of work of the monographs. If the Knowledge database does not list thesubstance you are looking for, this means that no monograph is available.

“知识数据库”里提供了各论的目前状态。如果知识数据库里没有列出你要找的物质，则表示目前还没有该物质各论。

来源：

http://zhuyujiao1972.blog.163.com/blog/static/9869472720151121105656963/