9/10 May 2023
Last week, the EMA confirmed that the clinical trial EU Portal and Database (Clinical Trial Information System (CTIS)) is now fully functional and on track to go live by 31 January 2022.
This would imply that the Commission notice in the Official Journal would be published on 31 July 2021. The EU Clinical Trial Regulation (CTR EU No 536/2014) will then come into first operation six months after the notice of the full functionality of the CTIS. The CTR aims to harmonise the registration and supervision processes for clinical trials throughout the EU.
When it goes live, the CTIS will be the single EU entry point for clinical trial applications. Clinical trial sponsors will then be able to apply for a clinical trial with one application instead of having to apply separately in every country. The single application will include the submission to national competent authorities and to ethics committees. In addition, instead of the current EU GMP Annex 13 (Manufacture of IMPs), the Detailed Commission guidelines on GMP for IMPs for human use will then apply.
For more information please see EMA´s announcement Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation.