Multidisciplinary: Nanomedicines

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This page lists the European Medicines Agency's scientific guidelines on nanomedicines.

If you have comments on a document that is open for consultation, use the form for submission of comments on scientific guidelines.

TopicDocumentsReference numberPublication dateEffective dateRemarks
Data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

Overview of comments

Reflection paper

Draft reflection paper

EMA/CHMP/SWP/620008/2012March 2015  
Non-clinical studies for generic nanoparticle iron medicinal product applicationsReflection paperEMA/CHMP/SWP/100094/2011March 2011 Superseded by EMA/CHMP/SWP/620008/2012
Surface coatings: general issues for consideration regarding parenteral administration of coated nanomedicine productsReflection paperEMA/325027/2013August 2013  
Data requirements for intravenous liposomal products developed with reference to an innovator liposomal productReflection paper
Draft reflection paper
CHMP/806058/2009/Rev. 02February 2013  
Development of block-copolymer-micelle medicinal productsReflection paper
Draft reflection paper
EMA/CHMP/13099/2013January 201410 January 2014Joint Ministry for Health, Labour and Welfare / European Medicines Agency document

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