title: Innovation in Phytotherapy: Is a New Regulation the Feasible Perspective in Europe?
abstract: Classical multicomponent preparations mostly derived from traditional usages in Western and Eastern phytotherapy have been under-evaluated for a long time as potential new pharmaceutical products. The regulatory scenario, in particular at the European level, has only recently considered these aspects proposing harmonized guidelines for the pharmaceutical registration of traditional herbal products. Nevertheless, a specific regulation for innovative products based on the combination of precious knowledge arising from traditional usages and modern scientific advancements is still missing. In this paper, we propose a critical review of the current situation with the specific aim of contributing to create a more favorable regulatory environment for the pharmaceutical registration of new and innovative herbal medicinal products.
authors.affiliation: Dipartimento di Scienze Farmaceutiche, Facoltà di Scienze del Farmaco - Università degli Studi di Milano, Milano, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Minghetti
authors.affiliation: Dipartimento di Scienze Farmaceutiche, Facoltà di Scienze del Farmaco - Università degli Studi di Milano, Milano, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Franzè
authors.affiliation: Dipartimento di Scienze Farmaceutiche, Facoltà di Scienze del Farmaco - Università degli Studi di Milano, Milano, Italy.
authors.forename: Viviana
authors.initials: V
authors.lastname: Zaccara
authors.affiliation: Loacker Remedia srl, Egna, Italy.
authors.forename: Floriana
authors.initials: F
authors.lastname: Raso
authors.affiliation: Indena S. p. A., Milano, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Morazzoni
mesh_terms: D005060:Europe; D029001:Herbal Medicine / Q000331:legislation & jurisprudence* / Q000639:trends; D006801:Humans; D007880:Legislation, Drug; D008517:Phytotherapy / Q000639:trends*