Remember the Clinical Trials Regulation? Much time has passed since its publication in 2014. No worries if your memory fails you: we have discussed the Clinical Trial Regulation at length in this article appeared on the Indian Law Journal of Law and Technology. If you prefer a shorter summary, you may read here what the European Medicines Agency has prepared for you.
The actual entry into force of the Clinical Trials Regulation depended on confirmation of full functionality of the Clinical Trials Information System (CTIS) through an independent audit, which occurred on April 21, 2021. Now, the go-live date for the CTIS will be on January 31, 2022. Information on the go live planning can be found here.
The Clinical Trials Regulation was born to address the prior directive’s shortcomings, and particularly to target the goals of harmonization and simplification in this field, also with a view of making Europe a competitive region in the global clinical trials market. Good luck to the CTIS: we hope the Clinical Trials Regulation keeps its promises!
EU Regulations on Clinical Trials number 536/2014 will enter into force 6 months after the publication of a notice by the EU Commission confirming that the clinical trial portal and databases have achieved full functionality in accordance with the required specifications.
Such clinical trial portal and database, where all information submitted through the portal will be stored, supposedly one of the high points of the Regulation, is probably its worst enemy so far. In fact, due to technical difficulties with the development of the IT systems (aka “CTIS”), the portal’s go-live date had to be postponed for years. Therefore, so far, the Directive continues to apply, while some argue that the Regulation – that appeared cutting edge in 2014 – already shows the signs of age.
Now things are finally moving ahead.
On April 21, 2021 the European Medicines Agency’s Extraordinary Management Board confirmed that “CTIS is fully functional and meets the functional specifications, following an independent, successful audit“.
The ball is now in the European Commission’s court: once the Commission confirms the same conclusions on CTIS, a notice will be published in the Official Journal of the European Union. “Six months after this notice, the Regulation will start to apply and CTIS will go live. The aim is that CTIS goes live on 31 January 2022.” says the EMA.