Updated Timeline for the Clinical Trial Regulation
Recommendation
2/3 April 2025
From QbD to Process Validation
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The European Medicines Agency, EMA, is still planning with January 2022 for the go-live date of the EU Clinical Trials Information System (CTIS) database and portal, and thus with the first application of the Clinical Trial Regulation (CTR, Regulation (EU) No 536/2014).
The Clinical Trials Regulation (CTR) has been in force since 2014. The date of its first application depends on the full functionality of the CTIS being confirmed by an independent audit. The CTR will become applicable six months after the publication of this confirmation by the European Commission (EC) in the Official Journal of the European Union.
The EMA will first review the findings of the system audit (Q4 2020). Subsequently, the usability, quality and stability of the CTIS will be improved and, at the same time, information will be provided to the users. In addition, a so-called Minimum Viable Product (MVP) is to be worked on together with the Member States. However, the contents (i.e. defined core functions of the CTIS) still have to be defined.
On their website, the EMA has published an update on the process of further activities after the audit.
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