title: Regulatory landscape for cell therapy--EU view.
abstract: This article addresses regulation of cell therapies in the European Union (EU), covering cell sourcing and applications for clinical trials and marketing authorisation applications. Regulatory oversight of cell sourcing and review of applications for clinical trials with cell therapies are handled at national level, that is, separately with each country making its own decisions. For clinical trials, this can lead to different decisions in different countries for the same trial. A regulation is soon to come into force that will address this and introduce a more efficient clinical trial application process. However, at the marketing authorisation stage, the process is pan-national: the Committee for Human Medicinal Products (CHMP) is responsible for giving the final scientific opinion on all EU marketing authorisation applications for cell therapies: favourable scientific opinions are passed to the European Commission (EC) for further consultation and, if successful, grant of a marketing authorisation valid in all 28 EU countries. In its review of applications for marketing authorisations (MAAs) for cell therapies, the CHMP is obliged to consult the Committee for Advanced Therapies (CAT), who conduct detailed scientific assessments of these applications, with assessment by staff from national regulatory authorities and specialist advisors to the regulators.
authors.affiliation: Medicines & Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, London SW1W 9SZ, UK. Electronic address: jw.mcblane@mhra.gsi.gov.uk.
authors.forename: James W
authors.initials: JW
authors.lastname: McBlane
mesh_terms: D064987:Cell- and Tissue-Based Therapy; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D005062:European Union; D006801:Humans
keywords: Advanced therapy medicinal products; Cell therapy; Clinical trials regulation; Committee for Advanced Therapies; European Medicines Agency; Marketing authorisation application