title: Nanotherapeutics in the EU: an overview on current state and future directions.
abstract: The application of nanotechnology in areas of drug delivery and therapy (ie, nanotherapeutics) is envisioned to have a great impact on public health. The ability of nanotherapeutics to provide targeted drug delivery, improve drug solubility, extend drug half-life, improve a drug's therapeutic index, and reduce a drug's immunogenicity has resulted in the potential to revolutionize the treatment of many diseases. In this paper, we review the liposome-, nanocrystal-, virosome-, polymer therapeutic-, nanoemulsion-, and nanoparticle-based approaches to nanotherapeutics, which represent the most successful and commercialized categories within the field of nanomedicine. We discuss the regulatory pathway and initiatives endeavoring to ensure the safe and timely clinical translation of emerging nanotherapeutics and realization of health care benefits. Emerging trends are expected to confirm that this nano-concept can exert a macro-impact on patient benefits, treatment options, and the EU economy.
authors.affiliation: Department of Pharmaceutical Technology, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, Croatia.
authors.forename: Anita
authors.initials: A
authors.lastname: Hafner
authors.affiliation: Department of Pharmaceutical Technology, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, Croatia.
authors.forename: Jasmina
authors.initials: J
authors.lastname: Lovrić
authors.affiliation: Medicines Authorisation Division, Agency for Medicinal Products and Medical Devices, Zagreb, Croatia.
authors.forename: Gorana Perina
authors.initials: GP
authors.lastname: Lakoš
authors.affiliation: Department of Pharmaceutical Technology, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, Croatia ; Centre for Applied Pharmacy, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, Croatia.
authors.forename: Ivan
authors.initials: I
authors.lastname: Pepić
mesh_terms: D003102:Colloids; D016503:Drug Delivery Systems / Q000639:trends; D004655:Emulsions; D005062:European Union; D006801:Humans; D007501:Iron / Q000008:administration & dosage; D008081:Liposomes / Q000008:administration & dosage; D008823:Micelles; D050997:Nanomedicine / Q000331:legislation & jurisprudence / Q000639:trends*; D053758:Nanoparticles / Q000008:administration & dosage; D036103:Nanotechnology / Q000639:trends; D057170:Translational Research, Biomedical / Q000639:trends; D022701:Virosomes / Q000008:administration & dosage
chemical_list: D003102:Colloids; D004655:Emulsions; D008081:Liposomes; D008823:Micelles; D022701:Virosomes; D007501:Iron
keywords: EU approval procedures; EU marketed products; drug delivery; nanotechnology