原创力文档Draft guideline on quality and equivalence of topical producys.(EMA)外用制剂的质量和等效性的指导原则草案.pdfVIP
- 1、本文档共36页，可阅读全部内容。
- 2、原创力文档（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。
- 3、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击 这里二次下载。
- 4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。
- 5、该文档为VIP文档，如果想要下载，成为VIP会员后，下载免费。
- 6、成为VIP后，下载本文档将扣除1次下载权益。下载后，不支持退款、换文档。如有疑问请联系我们。
- 7、成为VIP后，您将拥有八大权益，权益包括：VIP文档下载权益、阅读免打扰、文档格式转换、高级专利检索、专属身份标志、高级客服、多端互通、版权登记。
- 8、VIP文档为合作方或网友上传，每下载1次， 网站将根据用户上传文档的质量评分、类型等，对文档贡献者给予高额补贴、流量扶持。如果你也想贡献VIP文档。上传文档
查看更多
1 18 October 2018
2 CHMP/QWP/708282/2018
3 Committee for Medicinal Products for Human Use (CHMP)
4 Draft guideline on quality and equivalence of topical
5 products
6
7
Draft Agreed by QWP 7 June 2018
Adoption by CHMP for release for consultation 18 October 2018
Start of public consultation 14 December 2018
End of consultation (deadline for comments) 30 June 2019
Agreed by QWP
Adopted by CHMP
Date for coming into effect
8
9 Annexes I and II of this guideline replace Annex 1 of the Guideline on Quality of Transdermal Patches
10 (EMA/CHMP/QWP/608924/2014)
11 The guideline replaces Questions and Answer on Guideline: Clinical Investigation of Corticosteroids
12 Intended for Use on The Skin CHMP/EWP/21441/2006.
13
14
Comments should be provided using this template. The completed comments form should be sent to
QWP@ema.europa.eu
15
16
Keywords Medicinal products for cutaneous use, topical products, locally applied
locally acting medicinal products, skin permeation, in vitro release,
stratum corneum sampling, tape stripping.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520
Send a question via our website www.ema.europa.eu/contact An agency of the European Union
© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
17 Draft Guideline on quality and equivalence of topical
18 products
19
20 Contents
21 Executive summary 4
22 1 Introduction and Backgr
文档评论（0）