Identification of regulatory needs for nanomedicines

Author:

Bremer-Hoffmann Susanne1,Halamoda-Kenzaoui Blanka1ORCID,Borgos Sven Even2

Affiliation:

1. European Commission Joint Research Centre (JRC); via E. Fermi 2749 21027 Ispra VA Italy

2. SINTEF Materials & Chemistry; Dept. of Biotechnology and Nanomedicine - Research Group Mass Spectrometry; Sem Saelands v. 2A 7034 Trondheim Norway

Funder

European Union's Horizon 2020 Framework Programme

Publisher

Wiley

Reference39 articles.

1. Summary report of PQRI workshop on nanomaterial in drug products: current experience and management of potential risks;Bartlett;AAPS J.,2015

2. Committee for Medicinal Products for Human Use 2013a Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products

3. Committee for Medicinal Products for Human Use 2013b Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product EMA/CHMP/806058/2009/Rev.02

4. Committee for Medicinal Products for Human Use 2013c Reflection paper on surface coatings: general issues for consideration regarding parenteral administration of coated nanomedicine products. EMA/325027/2013

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