Transition of clinical trials
On 30 January 2025 the transition period will be over. After that date, the sponsor of ongoing* CTD (Clinical Trials Directive 2001/20/EC) clinical trials without CTR approval must submit a complete new clinical trial application for approval in CTIS (Clinial Trials Information System) portal according to Clinical Trials Regulation (CTR 536/2014) rules.
The rules set out for transition applications will not be applicable for new applications going forward this means:
- No possibility to submit a reduced package in line with the transition guidance documents published, nor possibility to classify the application as transition application
- No expedited administrative procedure which was possible during the transition, instead the application will be handled as an initial clinical trial application
Clinical trials that have not been submitted for transitioning process in the CTIS portal latest on the 30th of January 2025 will be considered non-compliant with legislation and in breach of the CTR. Consequently, sponsors could be subject to corrective measures and penalties by Fimea in accordance with Articles 77 and subject to liability as per Act on Clinical Trials on Medicinal Products (983/2021) 31-32§.
The decision to take corrective action will be assessed on a case-by-case basis. Fimea will approach such sponsors through a hearing of the view of a party process, whereby sponsors can express their views within one week. After that, Fimea may to undertake a corrective measure under Article 77 of the CTR, such as revocation of the approval of the clinical trial.
The sponsors with ongoing* CTD mono-national clinical trials, which have not been transitioned or submitted for transitioning process latest on the 30th of January 2025, should contact Fimea as soon as possible. In case of a multi-national trials, the RMS intended to be proposed for the application shall be contacted.
* Trials which have at least one active centre (active centres are those sites where treatment or follow-up is taking place according to the protocol, either by contacting the patient from the site (e.g. by telephone) or by the patient physically coming to the site for a follow-up visit according to the protocol. If the monitoring is done according to the protocol so that only the registers provide the information, no transition is necessary.)
Submission of the results of trials under the Directive
The sponsor or principal investigator shall submit a report on the trial results to Fimea within one year of its completion. If any of the subjects were under 18 years of age and the sponsor is the marketing authorisation holder of the investigational medicinal product, the report shall be submitted within six months. The report shall be submitted in the form of a summary, a synopsis, published article or in some other similar way in writing. An extensive trial report containing complete research data only needs to be supplied if Fimea so requests.
Additionally, the results shall be submitted to the EU register of clinical trials. The sponsor shall register in the EudraCT database of the European Medicines Agency as a supplier of results. The results of trials that were terminated early or ended before 21 July 2013 can be submitted to EMA’s register as pdf files. Further information about the extent of the submission of results is available in this table (pdf).
More detailed information about the submission of results can be found on the EMA website.
Trial results may also be submitted to the EudraCT database after the transitional period.
Submitting material to Fimea
The results of trials under the Directive shall be submitted to Fimea via CESP or using Fimea’s secure e-mail. (Instructions for the submission of materials (pdf).)