Clinical Drug Trials
Clinical Drug Trials
Fimea must be notified of interventional clinical trials on medicinal products, regardless of whether the investigational medicinal product has marketing authorisation or not.
Fimea need not be notified of investigations other than interventional trials. These non-interventional trials must meet the following criteria: Medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation.
The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient 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 collected data
In the case of any uncertainty, Fimea will decide whether a notification for a clinical trial on medicinal products should be submitted.
Notification of a clinical trial shall be made using the Clinical Trial Application Form available on the EMA EudraCT database website. Instructions on completing and sending the form are available on the Fimea and EMA websites.
The new Administrative Regulation 8/2019 of the Finnish Medicines Agency Fimea concerning clinical trials will enter into force on 1 January 2020. It will supersede Fimea’s previous regulation 2/2012.
Following the entry into force of the new regulation, all material related to clinical trials shall be submitted to Fimea electronically (instructions for submitting).
The amount of payment for a clinical trial notification is 3000 €. In the case of trials involving medicinal products for gene therapy, somatic or xenogenic cell therapy or medicinal products containing genetically modified organisms the amount of payment for an application is 3300 € according to the Ministry of Social Affairs and Health.
The processing of substantial amendments to clinical trials will be subject to charge at Fimea as of 1 January 2020 (processing fee €900).
After validation Fimea sends invoices to the customers on the basis of new clinical trial applications and substantial amendments. New customers should provide their invoicing data to Fimea invoicing registry in a customer register update form. More information is available on Fimea's website under Fees or from talous (a) fimea.fi. The sender should clearly indicate in the cover letter all additional information (i.e. company reference, PO number, project code) needed for the invoice processing.
A waiver of processing fee may be requested in respect of a notification relating to a clinical trial on a medicinal product conducted by an individual investigator, a trial team, a university institute, 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 notification concerning a trial must be accompanied by an informal statement to the effect that the investigation will not receive any outside financing. Medicinal products received free of charge for the purpose of the investigation are not deemed outside financing.
Report on the clinical trial results
The sponsor or the person responsible for the trial must provide Fimea with a report on the results of the trial not later than one year after it ends. If the trial subjects have included persons under the age of 18 and if the sponsor is the marketing authorisation holder for the investigational medicinal product, the report must be submitted within six months. The report should be submitted in the form of a summary, a synopsis, published article or in some other similar way. An extensive trial report containing complete research data only needs to be supplied at the request of Fimea.
The report on the results must also be submitted to the EU Clinical Trials Register. The sponsor should register as a results user in the EudraCT. Please see European Commission guideline on posting and publication of results-related information on clinical trials.
VHP (Voluntary Harmonisation Procedure)
The VHP is a Voluntary Harmonisation Procedure by EU Member States, supported by the Heads of Medicines Agencies (HMA), in multinational clinical trial applications. The purpose of the VHP is to harmonise the processing of a clinical trial, with the preliminary VHP application being processed in selected Member States before the submission of a national clinical trial application. Fimea has participated actively in the joint European clinical trial harmonisation process since 2015. Finland can choose to act either as a Reference Member State, in other words a reporting member state, or as a Concerned Member State.
After VHP processing, a statutory national application procedure is required, which means that, following a joint assessment, a clinical trial application must be submitted to Fimea – just as in ordinary national applications. The covering letter of a national application must indicate VHP participation (VHP number) and the applicant's solemn declaration stating that the application has not been modified since the VHP. The processing time for national application submissions after the VHP is 10 days.
clinicaltrials (a) fimea.fi