EU Regulation 536/2014
EU Regulation 536/2014
The Regulation of the European Parliament and of the Council on clinical trials on medicinal products has been published in the Official Journal of the European Union on 27 May 2014 (L158).
The Regulation replaces the national notification and authorisation procedures with a pan-European authorisation procedure where the maximum processing times are shorter than the current ones. The Regulation also contains other changes whose purpose is to facilitate the conduction of clinical trials and their transparency in the European Union.
Regulation No 536/2014 was adopted on 16 April 2014 and it will enter into force 31.01.2022 with the Clinical Trials Information System and database maintained by the European Medicines Agency.
The implementation of the Regulation is prepared under the direction of the European Commission and the European Medicines Agency; in Finland, the directing organisation is the Ministry of Social Affairs and Health.
National pilot (new applications are not accepted to pilot)
Fimea and the National Committee on Medical Research Ethics (TUKIJA) are piloting the EU Regulation in Finland. By participating in the pilot, the sponsors of clinical trials will have the opportunity to prepare for the application of the new Regulation.
Participation in the pilot is voluntary. Applications for new clinical trials and substantial modifications are needed for the pilot. The sponsor may propose the piloting of the substantial modification regardless of whether the original protocol has been included in the pilot.
The clinical trials in pilot are assessed separately at Fimea and TUKIJA, in accordance with the legislation currently in force. Thus parts I and II are always taken into process simultaneously. The assessment procedure and processing times pursuant to the EU Regulation will be taken into account in the pilot where applicable. The aim is to provide sponsor with Fimea's and TUKIJA's assessments at the same time but this cannot be quaranteed.
How can sponsors participate in the piloting?
Sponsors may express their interest in participating the pilot in the cover letter accompanying the advance notification filed with TUKIJA. Sponsors interested in piloting substantial modification applications are requested to contact TUKIJA and Fimea well in advance before submitting their modification application and also to note TUKIJA’s deadlines for submissions.
Click the links for further information about how to file an advance notification and deadlines for filing the notification as well as for the advance notification form and instructions for filling out the form (only in Finnish). In addition, sponsors will be requested to give their consent for TUKIJA and Fimea, in order to share documents related to application in the pilot process.
Fimea and TUKIJA will choose the clinical trial applications that are suitable for the pilot and inform all those who expressed their interest whether the application will be included in the pilot or whether it will be assessed in accordance with the current practice.
Only a limited number of clinical trial applications will be admitted to the pilot, and applications concerning investigational ATMPs, the COVID-19 pandemic or in VHP process will be excluded from it. The same delineation applies for substantial modifications of these applications. Neither modifications concerning only IMPD dossier nor those regarded as non-substantial can be taken into pilot process.
No safety assessments will be carried out in the pilot.
Description of the national pilot
1. The sponsor expresses its interest to participate in the national pilot of the EU Regulation in the cover letter accompanying the advance notification submitted to TUKIJA.
2–3. TUKIJA makes the decision as to whether the clinical trial will be admitted to processing by TUKIJA or whether the processing will be referred to a regional ethical committee. TUKIJA informs the sponsor of the decision and gives further information and instructions on the implementation of the pilot and the processing of the application.
4. The sponsor registers as a user of the Tiimeri workspace as instructed and submits the dossier in the protected folder created for the sponsor.
5. Fimea and TUKIJA validate the application (3 days*) and, if applicable:
5.1. They present a request for supplementary documents.
5.2. The sponsor submits the comments and supplements to application to the Tiimeri workspace (5 days*).
6. Based on the validation of the application, Fimea and TUKIJA assess whether the clinical trial is eligible for the pilot. The sponsor is informed of the result.
7. The processing of the application by Fimea and TUKIJA is commenced with the initial assessment and coordinated review (26 days*) and, if applicable:
7.1. Fimea and TUKIJA present a request for additional information to the sponsor.
7.2. The sponsor submits the additional information to the Tiimeri workspace (12 days*).
7.3 Fimea and TUKIJA asses the additional information and prepare a notification of the processing / statement (19 days*).
8. The processing of the application by Fimea and TUKIJA is closed (5 days*). Fimea’s notification of the processing and TUKIJA’s statement are served on the sponsor in the Tiimeri workspace.
*The days in brackets indicate the longest possible duration of the assessment phase in question (this phase may also be shorter).
The closing of the pilot project will be announced on this page. According to the current estimate, the pilot will last until the autumn of 2021.
Assessment of the results of the piloting and submission of feedback
Fimea and TUKIJA will assess the results of the pilot during the project and may change the content or process of the pilot if deemed necessary. The results of the pilot will be announced in the ‘What’s new’ section of this page.
Development ideas concerning the pilot can be sent to the common mailbox (in the subject field, enter ‘development ideas’). Additionally, the sponsors selected to the pilot will be requested to give feedback via an online survey (a link to the online survey will be sent to the sponsors during the pilot).