Trials under the directive during the transitional period

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Trials under the directive during the transitional period

The Regulation on Clinical Trials 536/2014 sets out a three-year transitional period as follows:

31 January 2022 to 30 January 2023 

  • The sponsor may submit a new clinical trial for processing by authorities either in the CTIS system in accordance with the Regulation or for national processing only in accordance with Directive 2001/20/EC. 

Starting from 31 January 2023

  • All new clinical trials will be processed in accordance with the Regulation, meaning that they must be submitted for assessment by the authority in the CTIS system.

31 January 2023 to 30 January 2025

  • Any material to trials submitted nationally under the Directive (modification and termination notifications, annual reports, results) will be processed in accordance with the Directive. 

By 30 January 2025 at the latest, the studies must have been completed or transferred to the CTIS system in accordance with the Regulation. More information on the transitional period and on transferring the trial under the Regulation can be found in the Questions & Answers document on the European Commission's EudraLex - Volume 10 website. The Clinical Trials Facilitation Group (CTFG) has also compiled a Best Practice Guide for transferring an international trial under the Directive under the Regulation.

Clinical trials under Directive 2001/20/EC 31.01.2023 - 30.01.2025

The clinical trials processed in Fimea in accordance with the EU Directive (2001/20/EC) and the national regulations issued thereunder can continue as before until the end of the transitional period. Fimea's Administrative Regulation 8/2019, for example, will apply to these trials.

Notifying substantial amendments to protocols of trials under the Directive and the end of a trial

In the event of substantial amendments to the trial protocol, the Substantial Amendment Notification Form available on the European Commission website shall be filled out, and when the trial ends, the Declaration of the End of Trial Form shall be filled out accordingly.

In case the information in the EudraCT-form changes, the updated form (pdf and xml) will be included in the next amendment notification to Fimea.

When filling out the notification form, note the following:

  • Even though the form is in English, it can be filled out in Finnish or Swedish.

  • Use the Next, Done and Return buttons in the form to navigate between screens. Do not use the browser's navigation buttons. Click the CTA Sections A to H of the notification form to fill out the form.

  • It is advisable to frequently save the information entered in the electronic form locally on your computer by selecting Save as XML from the main menu.

  • The information entered in the fields marked in green on the form will become public in the EU Register of Clinical Trials.

Instructions for filling out the notification form: EudraCT Help.

If a non-commercial trial is carried out on medicines authorised in Finland, a simplified guide (in Finnish) can be followed when filling out the EudraCT notification form. Sufficient minimum information is indicated in the instructions, other information can also be given if applicable.

The EudraCT form is saved as .xml and .pdf files. Along with the trial notification, a notification form in .xml format, accompanied by a signed notification form, shall be submitted to Fimea in electronic format. You should also save both formats for yourself for later use.

Fimea reviews the information and submits them to the EU authority’s EudraCT database.

Payments

For the purposes of invoicing, the substantial modification applications must be accompanied by the details of the party to be invoiced complete with any reference information. For instructions on how to state the invoicing information, see the Fimea website, section Fees, Customer data reporting form.

Exemption from processing fee may be requested in respect of a notification relating to a clinical trial conducted by an individual investigator, a team of investigators, a university department, a university hospital clinic or the National Institute for Health and Welfare without outside financing or with financing by a non-profit corporation. In these cases, the application for authorization must be accompanied by a free-form statement attesting that the trial will not receive any outside financing. Medicinal products received free of charge for the purpose of the trial are not considered as outside financing.

Transferring a clinical trial approved under the Clinical Trials Directive to CTIS system and under the Clinical Trials Regulation will not be charged.

In the clinical trials under Directive the payment for an application are set out in the Decree of the Ministry of Social Affairs and Health (798/2022 STM). 

Voluntary Harmonisation Procedure (VHP)

Clinical trials that have undergone the Voluntary Harmonisation Procedure (VHP) may be continued under the Directive for the duration of the transitional period. The sponsor may choose to transfer the trial to the CTIS system to continue it under the EU Regulation. The transfer must be made at the latest when the trial continues beyond the transitional period. 

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.

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 material 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.)