Main changes in European Clinical Trials Regulation (No 536/2014)

Contemporary Clinical Trials Communications
E TentiG Martinelli

Abstract

The new Regulation (EU) No. 536/2014 for clinical trials of medicinal products for human is part of a European regulatory framework in which the European Commission has wished to give a strong impetus to scientific research and industrial progress. It is a new regulation that fills a series of regulatory gaps in the Clinical Trials through the creation of a uniform framework for the authorization of clinical trials by all interested Member States with a single assessment of the results. The Regulation thus facilitates cross-border cooperation to make the clinical tests wider and encourage the development of special treatments, for example for rare diseases, but above all streamlines the rules on clinical trials across European Union (EU), introducing simplified rules for experimentation so-called 'low level of intervention', on which much has been discussed and still arouses concern, providing for authorized medicines or used off-label in the presence of scientific evidence published on efficacy and safety and to benefit from they will be mainly the pediatric and oncological therapeutic areas. The applications and any communication will be submitted paperlessly via a new electronic EU portal. The complex processing procedures a...Continue Reading

Citations

Mar 12, 2019·Drug Development Research·R Neethu, Timo Minssen
Mar 19, 2019·Clinical and Translational Science·Davy ChiodinSarah H Lockwood
May 7, 2020·Epidemiology and Psychiatric Sciences·Giovanni OstuzziCorrado Barbui
Oct 15, 2019·Expert Review of Clinical Pharmacology·Cristina ScavoneAnnalisa Capuano
Feb 1, 2020·BMJ : British Medical Journal·Mark Dayan
May 10, 2019·Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz·Dirk Lanzerath
Oct 30, 2019·EJNMMI Radiopharmacy and Chemistry·Iván PeñuelasPhilip H Elsinga
Dec 4, 2020·Tissue Engineering. Part B, Reviews·Darren Shu Jeng TingJodhbir Mehta
Feb 4, 2021·Amyotrophic Lateral Sclerosis & Frontotemporal Degeneration·Paul LingorMichael Benatar
May 3, 2021·BMC Medical Ethics·Marcin OrzechowskiFlorian Steger
Jan 29, 2020·Annals of Oncology : Official Journal of the European Society for Medical Oncology·S VignotE Chapel

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