The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the political agreement reached by the European co-legislators, with the aim of a rapid adoption of the new Regulation on Clinical Trials. However, the original objectives of this legislation should be remembered: to enhance efficiency in the clinical trials regulation process and, in turn, to boost the European Union's competitiveness as a place to conduct research and make for more efficient patients access to new innovative treatments. EFPIA believes some of the initial objectives of the legislation have been only partially achieved; therefore, the success of this legislation strongly depends on how it will apply in practice.
When establishing further legislation and procedures at the European and at the national level, it will be essential relevant stakeholders have the opportunity to provide input for remaining questions and concerns. This is necessary to ensure the legal revision achieves its objectives of establishing a streamlined and a more harmonized system in the E.U.
The new regulation includes a number of provisions that will allow for a better coordinated and more efficient approach, which will be directly binding to member states and sponsors. Key advances include a single submission of a clinical trial application to the future E.U. portal and database, and a defined and coordinated assessment procedure integrating review by competent authorities and ethics committees. The outcome of this review leads to a single administrative decision per member state. Additionally, the provisions to ensure safety and integrity of clinical trials participants have been further clarified.
While the legal framework provides for the possibility to apply extended assessment timelines, it now is up to each member state to establish processes and practices with timelines, which can still be considered competitive compared to other regions. EFPIA calls on member states to consider the impact of timelines on the overall attractiveness to conduct clinical research both in each member state and in Europe as a region.
In detail, EFPIA calls on the European Commission, the EMA and the member states to address the following points during the implementation phase:
The future Clinical Trials Advisory Group CTAG should take a key role in monitoring the functionality of the regulation of such metrics and this should be vested in the rules of procedures. EFPIA and its member companies, as the largest contributors to clinical research in Europe, stand ready to provide the necessary input in order to assist in facilitating a regulation that meets the original objectives.