title: Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines.
abstract: Over the last three decades many first-generation nanomedicines have successfully entered routine clinical use and it is now important for medicines regulatory agencies to consider the mechanisms needed to ensure safe introduction of 'follow-on' nanomedicine products, 'nanosimilars'. Moreover, drug regulators need to ensure that 'next'-generation nanomedicines enter clinical development and consequently the market in a safe and timely way for the benefit of public health. Here we review recent European Medicines Agency activities that relate to the effective development and evaluation of nanomedicine products while keeping patient and consumer safety at the forefront.
authors: Nanomedicines Drafting Group, European Medicines Agency, 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK. falk.ehmann@ema.europa.eu
authors: Falk
authors: F
authors: Ehmann
authors: Kumiko
authors: K
authors: Sakai-Kato
authors: Ruth
authors: R
authors: Duncan
authors: Dolores
authors: D
authors: Hernán Pérez de la Ossa
authors: Ruben
authors: R
authors: Pita
authors: Jean-Marc
authors: JM
authors: Vidal
authors: Ashish
authors: A
authors: Kohli
authors: Laszlo
authors: L
authors: Tothfalusi
authors: Alan
authors: A
authors: Sanh
authors: Sandrine
authors: S
authors: Tinton
authors: Jean-Louis
authors: JL
authors: Robert
authors: Beatriz
authors: B
authors: Silva Lima
authors: Marisa Papaluca
authors: MP
authors: Amati
mesh_terms: D055808:Drug Discovery / Q000331:legislation & jurisprudence*; D004335:Drug and Narcotic Control; D005060:Europe; D006077:Government Agencies; D006801:Humans; D050997:Nanomedicine / Q000331:legislation & jurisprudence*; D049329:Nanostructures / Q000627:therapeutic use