Transition period

This transition period is as follows (see also question 1.2 of the Q&A CTR):

• 1st year: initial application according to old (Directive 2001/20/EC) and new legislation (CTR) is allowed
• 2nd and 3rd year: all initial applications according to the CTR
• 4th year and later: all ongoing clinical trials should comply with the requirements of the CTR

During the three years transition period, substantial modifications of clinical trials approved under Directive 2001/20/EC can be submitted according to this old legislation.

Clinical trials not authorised under the regime of the CTR and still ongoing in EEA (Last Visit Last Patient has not taken place yet) at the end of the transitional period have to be ended or should switch before the end of this period into the regime of the CTR. If the duration of the clinical trial is expected to be more than two years at the date of the primary application in the first year of the transitional period it is strongly recommended to apply for an authorisation under the regime of the CTR.

Clinical trials authorised under Directive 2001/20/EC

Clinical trials authorised on the basis of the Directive 2001/20/EC and still ongoing after 30 January 2025 should be transitioned to CTR. The sponsor is responsible for a timely switch to the new regime. Please refer to the dedicated CCMO webpage on transition trials for more information. Detailed guidance on the procedure for this transition is described in the European Commission Guidance for the transition of clinical trials, and the CTCG Best Practice Guide for sponsors on the transition of multinational clinical trials to CTR. For questions specific on the transition of EudraCT trials to CTIS, a document with frequently asked questions on EudraCT and CTR is also available.

Clinical trials authorised before Directive 2001/20/EC

There is no transition period for clinical trials authorised before the the Directive 2001/20/EC was applicable. In the Netherlands, the Directive 2001/20/EC came into effect on March 1, 2006. This means that all clinical trials authorised or submitted before March 1, 2006 and still ongoing at 31 January 2022 has to be ended or re-authorised under the CTR . These clinical trials do not have a Dutch national dossier number beginning with NL (NL12345.xxx.yy) and have no declaration of no objection from the competent authority (CCMO or Ministry of Health).  The sponsor should determine whether the clinical trial still fulfills the definition of a clinical trial or is a non-interventional study.  For instance, a study can be considered a non-interventional study if there is only a long-term safety follow-up ongoing via quarterly telephone calls or filling in simple questionnaires. These studies may continue without transition to CTR legislation.

If the trial is still to be considered as interventional and it is not possible to terminate a trial for reasons related to patient safety or scientific soundness, there are  two possible procedures to continue these trials at the time CTR is applicable:

• Submit a substantial amendment to the MREC and competent authority at least 3 months before the CTR is applicable  (31 January 2022) in which the clinical trial is brought in line with CTR legislation. The clinical trial must/has to be registered in the EudraCT  portal. After approval of the substantial amendment the transition rules for clinical trials authorised under Directive 2001/20/EC will apply; or
• Submit a full application dossier through CTIS as from 31 January 2022 and all CTR rules apply.