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Easier clinical trials in the European Community?

In 2014 the European Parliament approved the Regulation on clinical trials on medicinal products for human use (Regulation 536/2014) with the purpose to replace the several implementations of the 2001 Clinical Trial Directive.

The new Regulation aims at improving cooperation, sharing of information and decision-making process between and inside the Member States, increasing the transparency of clinical trial information and establishing safety standards for all stakeholders. The main scope would therefore be to make clinical trials easier to carry out in the EU.

This is the more demanding Regulation introduced by the European Commission in recent years; one that, once carried out, shall bring more harmonisation of the requirements between the Member States. Moreover, thanks to the submission of a single trial dossier through the EU portal – Clinical Trials Information System (CTIS) -, the improved assessment process will ensure resource efficiency for both sponsors and Member States and almost certain approval timetables.

However, 5 years later, the Regulation is still not applicable.

The European Medicine Agency (EMA), entrusted with the responsibility for the EU clinical trial portal and database (CTIS), provided for the launch of the system within December 2015. Due to technical difficulties, the date of the system starting was postponed several times.

Tests and corrections in the system key bugs were carried out in the spring of 2019. EMA recently published an update in their website declaring that a six-month monitoring report on the CTIS development has been approved, evaluating the performance of the provider based on the performance indicators. The Council agreed that the actions proposed should be further developed, for instance improving the quality of the work carried out by the developer and selecting the critical elements required for the audit, as well as extending the monitoring period to at least three releases.

Written by: Felisiano Cipressi