After a couple of years' delay, the Management Board of the European Medicines Agency has confirmed that the EU portal and the database for clinical trials will be fully functional and ready to take effect on 31 January 2022. On the same date, the Regulation on clinical trials is expected to apply to clinical trials in all Member States.
The EU portal and the database for clinical trials are key elements of the clinical trials information system (CTIS), a product of the regulation on clinical trials. The object of the Regulation is to harmonise the processes on registration and monitoring of clinical trials throughout the EU.
The Management Board of the European Medicines Agency (the EMA Board) has now confirmed that the EU portal and the database for clinical trials satisfy all functional specifications set out by EMA, the EU Commission and Member States. The conclusion comes in the wake of an independent review of the new IT system, which has assured the EMA Board that the system is ready for implementation. The implementation of CTIS has been delayed for many years due to technical problems with the underlying IT system.
Regulation on clinical drug trials
Regulation (EU) no. 536/2014 on clinical trials on medicinal products will apply six months from the date on which the EU Commission announces that the EU portal and the database are completed. The Regulation includes amendments to, for instance, rules on trials in emergency situations, risk-based requirements to application material, shorter deadlines in the case processing, and simplified rules on safety reporting in the trial period.
The Regulation introduces various new measures in relation to application, deadlines and communication with authorities, while maintaining key principles of the current Directive 2001/20/EC on good clinical practice in the conduct of clinical trials. Various quality standards for the different trial stages and for the handling of data are also maintained.
Benefits of the new system
According to the EMA Board, the implementation of CTIS will increase the efficiency in the registration and monitoring of clinical trials in the EU, including in particular for the clinical trials conducted in several Member States. Moreover, it will ensure transparency towards the public. The system will also increase the EU's value as a large and dynamic clinical research area, allowing authorities and researchers to collaborate more efficiently across Member States, ensuring better results and the sharing of knowledge. Finally, the public will enjoy more benefits from existing medicines and receive more information about clinical trials, as they are being conducted.
When CTIS takes effect, it will be the only portal for applications for clinical trials in the EU. Sponsors of clinical trials will be able to apply for clinical trials in all countries in the European Economic Area with just one application. Under the old set of rules, a sponsor had to apply separately in each country. The one application includes recommendation to the national competent authority as well as the ethical committee in all involved countries. The database will include data and information submitted through the EU portal for clinical trials and will, with very few exceptions, be publicly accessible.
The process going forward
The next step in the process is that the EMA Board will inform the EU Commission about its conclusions. When the EU Commission is satisfied and convinced that the conditions in the regulation on clinical trials are met, the Commission will publish an announcement in the Official Journal of the European Union. Six months after that, the Regulation on clinical trials and thus the CTIS will take effect.
In Denmark the Regulation on clinical trials on medicinal products is already implemented, albeit so that the Danish Minister of Health determines when the legislation will come into force. The Minister may decide that different parts of the legislation will come into force at different points in time. Before the legislation takes effect, it will be necessary to decide separately which of the existing rules on clinical trials on medicinal products and which adopted provisions in the bill will need to be repealed and at which time.