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International Clinical Trials

Business as Usual?

Regulation 536/2014 of the European Parliament and the Council on Clinical Trials on Medicinal Products for Human Use was adopted by the European Parliament on 2 April 2014 and would have gone into effect in 2016. The new Clinical Trials Regulation is aimed at repealing Directive 2001/20/EC, which was prone to interpretation by member states. Complexity under the former Directive caused the number of applications for studies in the EU to fall by 25% between 2007 and 2011, and delays of up to 152 days for launching trials to increase by 90%.

The application of the Clinical Trials Regulation has now been postponed to October 2018. Beginning at this date there will be a three-year transition period. It is aimed at harmonising and simplifying the submission of application dossiers and procedures for conducting clinical trials across all member countries, and its goal is to make the EU more attractive for clinical research and maintain high standards of patient safety. The Regulation is also anticipated to unify cooperation across member states.

The Specifics

With several primary components covered in the core text and appendices, the scope of the Regulation is extensive. Examples of this include authorisation procedures, start of trial, suspension and temporary holds, early termination, protection of subjects, safety reporting, clinical monitoring and transparency. Certain aspects, however, are not covered by the Regulation and remain country-specific, such as legal representation, site requirements, data protection, insurance and biological samples handling. Ultimately, it will enable an integrated application dossier process for regulatory and ethic committees approval through:
  • Part 1: the reporting member state performs a first assessment and the concernced member states review
  • Part 2: country- and site-specific documents are evaluated on a national basis by each concerned member state
  • Parts 1 and 2: reviewed in parallel or sequentially, depending on sponsor preference
  • Assessment of Part 1 remains valid for a period of two years unless there is any new scientific evidence


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Dr Martine Dehlinger-Kremer is Vice President of Global Medical and Regulatory Affairs at SynteractHCR. With over 30 years’ experience in the clinical research industry, she has contributed to the global development of numerous pharmaceutical products and devices, including participating in over 100 new drug and marketing authorisation applications. Martine is also President of the European CRO Federation, Chair of their Paediatric Working Group, a member of the EMA’s European Network of Paediatric Research working parties, a member of the board of European Forum for Good Clinical Practice and Chair of their Children’s Medicines Working Party.
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Dr Martine Dehlinger-Kremer
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