Clinical Trials in Europe: Dragging the New Rules into Operation

The entry into force of the new EU clinical trials regulation last June is really little more than a virtual event. The new rules will apply only once the EU Clinical Trials Portal and Database now under development are fully operational-and that isn't going to happen until 2016 at the earliest. In the meantime, there is a web of secondary legislation to be woven by the European Commission, which has to prepare and adopt a series of so-called delegated and implementing acts, as well as steer the process for the update of the related guidelines.

The steps needed to drag the necessary platform into place include a delegated act on Good Manufacturing Practice which will detail arrangements for inspections of investigational medicinal products, and an implementing act on detailed arrangements for Good Clinical Practice inspections, including qualifications and training requirements for inspectors. The Commission currently intends to adopt both of them by mid-2016. The necessary updated guidelines will cover GMP and voluntary sharing of raw data. And the Commission is also empowered to adopt an implementing act on cooperation among national authorities in assessing safety reporting-although it is waiting to see what comes out of discussions within the clinical trials facilitation group that national agencies operate before deciding on whether that will be needed. That group cooperates with the Commission and EMA in a specially-created clinical trials regulation coordination group that has been established to permit effective exchanges among the different bodies with responsibilities for putting the new regulation into real effect.

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