Clinical Drug Trials
Clinical Drug Trials new
An application for authorisation (or trial notification in accordance with Fimea’s Administrative Regulation 8/2019) must be submitted to Fimea on any clinical trial on medicinal products that intervenes with the inviolability of the trial subject in order to investigate the effects or properties of a medicinal product. The application for authorisation must be submitted regardless of whether the investigational medicinal product has a marketing authorisation or not.
An application for authorisation must only be filed on interventional trials. An application for authorisation is not to be filed on other investigations. Such other investigation (non-interventional study) meets the following criteria: In the investigation, medicinal product(s) is (are) prescribed in the usual manner in accordance with the conditions set out in the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance in the trial protocol but falls within the normal clinical practice, and decision to prescribe the medicinal product is clearly separate from the decision to include the subject in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of the collected data.
In unclear cases, Fimea may be consulted on whether an application for authorisation must be filed on the clinical trial. To expedite processing, it is advisable to enclose the trial protocol with the enquiry.
Trials under the EU Clinical Trials Regulation (536/2014)
The changes pertaining to clinical trials under the national legislation have entered into force on 31 January 2022 concurrently with the EU Regulation, with the exception that the provisions concerning the processing of personal data entered into force before this date. The Act on Clinical Trials lays down provisions on the matters required and enabled to be nationally regulated by the EU Regulation.
Following the entry into force of the EU Clinical Trials Regulation, sponsors shall submit trial applications electronically via a shared EU portal (Clinical Trials Information System, CTIS) maintained by the European Medicines Agency (EMA) on a centralised basis to all those Member States in whose territory each trial is intended to be conducted. The Member States’ medicinal authorities will assess the applications simultaneously, with the medicinal authority of one Member State acting as the reporting Member State and the authorities of the other Member States acting as concerned Member States.
Clinical Trial application from 31.01.2022, see Fimea's web page Trials under EU Regulation
The EU Regulation provides for a transitional period of one year during which sponsors may submit their applications either in accordance with the procedure laid down in the EU Regulation or in accordance with the EU Directive (2001/20/EC) and the national regulations issued thereunder.
New trials during the transitional period of 31.01.2022 to 30.01.2023: see Fimea's web page Trials under the EU Directive
The Ministry of Social Affairs and Health confirms the processing fees payable for clinical trials by its decree (fees for the trials according to the EU Regulation, fees for the trials according to the Directive).
Fimea will issue invoices based on the new notifications, permit applications and notifications of substantial amendments admitted for processing. The invoicing details of new customers shall be reported to Fimea using the customer data reporting form (see Fimea’s website for more information). The cover letter must clearly state the reference information (for example, reference number, PO code, project code), which must be shown in the invoice.
Exemption from the 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 Finnish Institute for Health and Welfare without outside financing or with financing from a non-profit organisation. In these cases, the application for authorisation 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.
Use of medicines containing genetically modified organisms in a clinical trial
If medicinal products containing genetically modified organisms are used in a clinical trial, a notification of, or application for, their use must also be filed in advance with the Board for Gene Technology. Their use will only be allowed if, based on the risk assessment conducted, it is not considered to be harmful to human health or the environment.
Submission of results
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 results of trials under the Directive shall be submitted both to Fimea and to the EudraCT database.
Trial protocol and trial subject information leaflet
The clinical trial protocol can be written on ones own template or using a pre-defined template (in Word format).
A template for the trial subject information leaflet and informed consent form is available (in Finnish) on the website of the National Committee on Medical Research Ethics Tukija.
Statistics on clinical trials
Statistics on clinical trials 2020 (link, in Finnish)
Fimea’s statistics on clinical trials for 2006–2019 can be requested by e-mail at firstname.lastname@example.org.
clinicaltrials (a) fimea.fi