Masterarbeit

National piloting activities in preparation of the new Clinical Trials Regulation Regulation (EU) No 536/2014 ***

Kathrin Mundt (2016)

Summary
Language: English
The Clinical Trials Regulation (CTR) EU No 536/2014 will lead to substantial changes in the regulatory framework for clinical trials in Europe and will particularly affect the national approval process for clinical trial applications (CTAs). The way how the Member States prepare themselves for these upcoming changes varies.
Germany and France have set up pilot projects to establish an interactive process which enables a joint/parallel assessment of the CTA dossier whereas Spain has decided to directly translate the CTR in their national law. The thesis outlines the regulatory situation in these three countries with respect to the current CTA approval process, the changes which are required in the national system and the road map for the respective legal implementation. Moreover, it describes the national pilot projects and discusses them in the context of the new CTR.
It can be summarised that although the timelines are strictly defined by the new CTR, the responsibilities for the assessment of part I and part II and also the setup of the ethics committee (EC) system will stay different in the countries. In France only one previously assigned EC will carry out the ethical review of the CTA which also might become reality in Germany whereas in Spain more ECs can be involved in case of a multicentre trial. In Germany and Spain the ECs will be involved in the part I assessment whereas in France the part I review will be solely performed by the national competent authority. Even though it is not possible at this stage to exactly mimic the new process as defined by the CTR – neither by the pilots (DE, FR) nor by a legal implementation (ES) approach - such concepts offer good opportunities for all stakeholders to get ready for the upcoming changes as the CTR timelines are very well reflected therein. However, the joint assessment can currently only be exercised on a national level as an EU-wide approach is not feasible yet as many Member States are still at the beginning of their preparation activities. At least it will turn out later – when the CTR becomes applicable - if the country-specific preparation activities had been useful to enable a smooth transition.
Pages: 66