Trials under the EU Regulation

Trials under the EU Regulation

Trials under the EU Regulation

The sponsor may submit clinical trials under the EU Clinical Trials Regulation (536/2014) for processing by the authorities starting from 31 January 2022.

The website of the European Medicines Agency (EMA) contains a wealth of up-to-date guidelines on the use of, and preparations for, the Clinical Trials Information System (CTIS).

The website of the European Commission contains guidelines and templates related to the application of the Regulation.

The logging page to the CTIS system can be found in the Clinical trials in the European Union -webpage. In the same page there is also the public EU Clinical Trials Register.

National legislation 

The Act on Clinical Trials (983/2021) lays down provisions on the matters required and enabled to be nationally regulated by the EU Regulation. These matters include:

  • the qualifications of an investigator conducting a clinical trial;
  • the language of application documents;
  • certain preconditions for medical examinations of subjects with reduced self-determination;
  • the main principles for the assessment responsibilities of Fimea and the ethics committee;
  • the principles of the fees charged to operators and compensation paid to subjects;
  • matters related to the processing of personal data in clinical trials; and
  • matters related to the supervision of trials.

The Act on Clinical Trials became applicable on 31 January 2022 concurrently with the EU Regulation. However, the provisions concerning the processing of personal data has already entered into force before. 

In Finland, both Fimea and the National Committee on Medical Research Ethics (Tukija) participate in the assessment of trials in the CTIS system and engage in cooperation where necessary to ensure a smooth assessment process.

Fimea regulation 6/2022 pertains to actions related to investigational medicinal products, such as labelling and manufacturing in hospital pharmacies.

Parts I and II of the trial

According to Annex 1 to the EU Clinical Trials Regulation (Application dossier for the initial application), the trial is divided into two parts, Part I and Part II, in the CTIS system.

Part I contains, among other things, the trial protocol, details of the products used in the trial, and the investigator’s brochure / summary of product characteristics. Part I also contains the details of the trial application. Part II includes, for example, the material to be given to the subject, details of the investigators and research centres, and insurance.

The sponsor may submit a trial application for both parts at the same time or first for Part I and then, within two years, for Part II. If the Part II application is not submitted within two years, the trial will laps. If the sponsor decides to only submit the Part I application first, the Part II application may only be submitted after the authorities have processed Part I.

Through the CTIS system, the sponsor will submit the Part I trial application simultaneously to the authorities of all the EU and EEA countries they have chosen, both to the medicinal authorities and to the ethics committees. 

Part II contains national documents, and only the authorities of the country concerned – in Finland, Fimea and Tukija – will participate in their processing.

A guide for a trialcentric organisation of how to create an application in CTIS portal has been published.

Clinical trial documents

The documents needed for the different clinical trial applications are listed in the appendices to the EU Clinical Trials Regulation:

  • Annex I Application dossier for the initial application
  • Annex II Application dossier for substantial modification
  • Annex III Safety reporting
  • Annex IV Content of the summary of the results of the clinical trial
  • Annex V Content of the summary of the results of the clinical trial for laypersons
  • Annex VI Labelling of investigational medicinal products and auxiliary medicinal products  a description of the labels of the investigational products used in Finland shall be submitted with Part I

Detailed instructions on the content requirements of the documents can be found from the Annexes to the Regulation.

Fimea’s regulation will pertain to the language of the labels, among other things.

Trial information and results are public

When the trial application has been approved, the trial documents will become public and visible in the EU database. Exceptions to the publicity principle include the quality documentation of investigational products and the authorities’ working versions of the assessment report.

A public version of the documents must always be added to the CTIS system. In addition, it is possible to also add another version of the same document that is only visible to the sponsor and the authority. 

The sponsor may apply for an extension to the publication of trial information when submitting a trial application.

Safety reporting

The reporting of unexpected serious adverse reactions by the sponsor will continue the same way as during the Directive.

Each year, the sponsor shall submit via the CTIS system a safety report on each investigational medicinal product used in a clinical trial. The same report may contain one or more investigational medicinal products.

The Member States will send any questions concerning the annual report via the CTIS system.

Further information about safety reporting is available on Fimea’s website.

Final report

The sponsor shall record a summary of the trial results in the CTIS system no later than one year after the end of the trial (Annex IV to the EU Clinical Trials Regulation). 

Additionally, the sponsor shall submit a summary of the results for laypersons (Annex V to the EU Clinical Trials Regulation).

The European Commission EudraLex - Volume 10 website contains general guidelines on preparing lay summaries.