{"title":"Where is European Regulation 536/2014 Taking Us?","authors":"Anthony W Fox","doi":"10.1007/s40290-023-00487-7","DOIUrl":null,"url":null,"abstract":"<p><p>The centralised clinical trial authorisation process, introduced by European Regulation 536/2014, came into force on 31 January 2022. The Regulation is inflexible, both legally and in the technical detail of the authorisation process itself. The principal justification for moving away from the older European Directive 2001/20 seems to be limited to multinational trials: multiple applications to national competent authorities (NCAs), would theoretically be replaced by a single, internationally harmonised authorisation. In fact, the Regulation itself reserves many powers to the NCAs, and the latter, in any case, can lawfully impose further requirements even after that harmonised approval; the year's experience reflects these disadvantages. It would have been better if Regulation 536/2014 had been written to allow the European Medicines Agency greater flexibility, and offered an alternative, optional approach to clinical trial authorisation in the European Union.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":null,"pages":null},"PeriodicalIF":3.1000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutical Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s40290-023-00487-7","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/6/24 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
The centralised clinical trial authorisation process, introduced by European Regulation 536/2014, came into force on 31 January 2022. The Regulation is inflexible, both legally and in the technical detail of the authorisation process itself. The principal justification for moving away from the older European Directive 2001/20 seems to be limited to multinational trials: multiple applications to national competent authorities (NCAs), would theoretically be replaced by a single, internationally harmonised authorisation. In fact, the Regulation itself reserves many powers to the NCAs, and the latter, in any case, can lawfully impose further requirements even after that harmonised approval; the year's experience reflects these disadvantages. It would have been better if Regulation 536/2014 had been written to allow the European Medicines Agency greater flexibility, and offered an alternative, optional approach to clinical trial authorisation in the European Union.
期刊介绍：
Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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