R&D-based pharmaceutical companies sponsoring clinical trials in the EU can catch their breath as they prepare for the application of Regulation (EU) No 536/2014 on clinical trials (Clinical Trials Regulation – CTR). On 16 June 2017, the EMA announced that the CTR will not become applicable before 2019, as opposed to October 2018 as previously scheduled. Such delay results from technical difficulties in the development of the IT infrastructure required by the CTR for all submission, assessment and reporting activities relating to clinical trials conducted in the EU.

The CTR establishes harmonised requirements directly applicable to all clinical trials conducted in the EU. The new system is pivoted on the single EU portal and EU database established by Articles 80-82 of the CTR. The EU portal will be a single entry point for the submission of clinical trial applications, data and information relating to EU clinical trials. All data and information submitted through the portal will be stored in the EU database and will be publicly accessible (see further details in our e-alert on the adoption of the CTR).

Although the CTR was adopted and entered into force in 2014, the timing of its application depends on the confirmation of full functionality of the EU portal and database through an independent audit under the responsibility of the EMA. The CTR will become applicable only six months after the European Commission will have published a notice of this confirmation in the Official Journal of the EU.

The EMA stated that it will provide industry with an update on the new delivery time frame after the next meeting of the Management Board in October 2017. In addition to the technical difficulties in the development of the CTR IT infrastructure, it remains to be seen whether the discussions around the EMA’s relocation triggered by Brexit will further affect the timing of application of the CTR.

Until the CTR becomes applicable, the current regulatory regime for clinical trials established by Directive 2001/20/EC and national implementing legislation remains in place. Meanwhile, EU member states have started to prepare for the CTR by issuing national legislation and running several pilot projects (see updates concerning Belgium, France, and Germany) to maximise competitiveness of their own R&D environments within the EU.