Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË – Tel. +32 22991111
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
The Director-General
Brussels
SANTE.D.2/LA
Subject: Ensuring full compliance with the Clinical Trials Regulation (EU)
536/2014 and its Delegated Acts from 31 January 2025.
Your Excellency,
I would like to bring to your attention that 30 January 2025 will mark the end of the three-
year transitional period in the Clinical Trials Regulatory framework. Consequently, as
from 31 January 2025, only the Clinical Trials Regulation (EU) 536/2014 (CTR) and its
Delegated Acts will apply.
On 31 January 2022, the Regulation repealed the Clinical Trials Directive 2001/20/EC and
national implementing legislations in the EU Member States. Article 98 of the Regulation,
read in conjunction with Article 99, describes the applicability of a 3-year transitional
period. This transitional period provides the possibility to transit the regulatory framework
under which a clinical trial is conducted, from the Directive to the Regulation, from the
day of the entry into application of the Regulation (i.e., 31 January 2022) until the end of
the 3-year transitional period (i.e., until 30 January 2025), without the need to discontinue
or put on hold an ongoing clinical trial.
From 31 January 2025 onwards, only the Regulation and its Delegated Acts will apply to
all clinical trials. This means that clinical trials authorised under the Clinical Trials
Directive 2001/20/EC and expected to be ongoing on and after 31 January 2025 must be
transferred into the legal framework of the Regulation by 30 January 2025 using the
Clinical Trials Information System (CTIS).
Should the clinical trials not have transitioned to the CTR by the end of the transitional
period contemplated in Article 98 of the CTR, these trials are to be considered as non-
compliant with the Regulation and:
• Sponsors may be subject to corrective measures by Member States pursuant to
Article 77 of the Regulation.
• Member States would be in breach of the Regulation provisions should they
refrain from taking the prescribed corrective measures after the transitional
period has elapsed.
The Commission has been working closely with the Member States and the European
Medicines Agency (EMA) to support commercial and non-commercial sponsors to transit.
However, based on the figures that the EMA has retrieved from its databases, too many
clinical trials still have to be processed. Thus, we foresee a surge of transitional trial
applications, especially closer to the end date of the transitional period.
Therefore, it is critical that Member States urge sponsors’ representatives in their country