EU: Clinical Trials Regulation – General Information & Guidelines (12-Mar-2015)

General information

All clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive(126 KB) until the new Clinical Trials Regulation (CTR) EU No 536/2014 (875 KB) will become applicable, which will be no earlier than 28 May 2016. For further information please see the information on the Clinical trials Directive and the transition period .

• The new Clinical Trials  legislation, which was adopted on 16 April 2014 and entered into force on 16 June 2014,  has taken the legal form of a Regulation. This will ensure that the rules for conducting clinical trials are identical throughout the EU. This is vital to ensure that Member States, in authorising and supervising the conduct of a clinical trial, base themselves on identical rules.
• The Clinical Trials Regulation aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States.
• The main characteristics of the new Regulation are:
  • A streamlined application procedure via a single entry point, the EU portal.
  • A single set of documents to be prepared and submitted for the application defined in Annex I of the Regulation;
  • A harmonised procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is jointly assessed by all Member States concerned. Part II is assessed by each Member State concerned separately.
  • Strictly defined deadlines for the assessment of clinical trial application;
  • The involvement of the ethics committees in the assessment procedure in accordance with the national law of the Member state concerned but within the overall timelines defined by the Regulation.
  • Extension of the tacit agreement principle to the whole authorisation process which, without compromising safety, will give sponsors, in particular SMEs and academics, increased legal certainty;
  • Simplified reporting procedures which will spare sponsors from submitting broadly identical information separately to various bodies and different Member States;
  • Increased transparency as regards clinical trials and their outcomes;
  • Union controls in Member states and third countries to ensure that clinical trials rules are being properly supervised and enforced.
  • Clinical trials conducted outside the EU, but referred to in a clinical trial application within the EU, will have to comply with regulatory requirements that are at least equivalent to those applicable in the EU.
• The Clinical Trials Regulation has taken up certain provisions from two relevant Directives:
  •  The Commission Directive 2005/28/EC(263 KB)  of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products” (Good Clinical Practice – ” The GCP Directive), an
  •  The Commission Directive 2003/94/EC (208 KB) of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, (the GMP Directive(208 KB) ).
• Both the GCP and GMP Directive, to the extent that they concern investigational medicinal products, will be replaced by the new acts:
  • An Implementing Regulation on detailed arrangements for inspections procedures on GCP, including qualifications and training requirements for inspectors and;
  • A Delegated Regulation on the GMP rules for Investigational Medicinal Products.

However, during the transitory period the CGP and GMP Directives referred above will continue to apply for the clinical trials authorised under Directive 2001/20.
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