title: Addressing the regulatory and scientific challenges in multiple sclerosis--a statement from the EU regulators.
abstract: Improving and facilitating the process of making new drugs available to patients with multiple sclerosis (MS) requires cooperation among the regulators and other stakeholders. This cooperation will also positively contribute towards developing guidelines of the highest quality in medical, regulatory and scientific aspects. This would be beneficial both in areas that require further guideline development, but also in fields where existing guidance should be adapted to take into account evolution in science. Considering the input from all stakeholders, the European Medicines Agency confirmed its intention to update the relevant guideline and apply a flexible approach towards new drug development strategies in MS. This article is the first official position from the EU regulators, presenting the main changes to be expected in the guidance document.
authors.affiliation: European Medicines Agency, UK pavel.balabanov@ema.europa.eu.
authors.forename: Pavel
authors.initials: P
authors.lastname: Balabanov
authors.affiliation: European Medicines Agency, UK.
authors.forename: Manuel
authors.initials: M
authors.lastname: Haas
authors.affiliation: Medicines Evaluation Board, The Netherlands.
authors.forename: Andre
authors.initials: A
authors.lastname: Elferink
authors.affiliation: Hospital Maison Blanche, Reims, France.
authors.forename: Serge
authors.initials: S
authors.lastname: Bakchine
authors.affiliation: Federal Institute for Drugs and Medical Devices, DE, Germany.
authors.forename: Karl
authors.initials: K
authors.lastname: Broich
mesh_terms: D003299:Cooperative Behavior; D004185:Disability Evaluation; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000592:standards* / Q000639:trends; D023381:Endpoint Determination / Q000592:standards; D005062:European Union; D033161:Government Regulation; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D033183:Interdisciplinary Communication; D007373:Interinstitutional Relations; D009103:Multiple Sclerosis / Q000175:diagnosis / Q000188:drug therapy*; D018579:Patient Selection; D011237:Predictive Value of Tests; D012107:Research Design / Q000331:legislation & jurisprudence* / Q000592:standards* / Q000639:trends; D016896:Treatment Outcome
keywords: Multiple sclerosis; drug development; regulatory requirements