Frequently asked questions about Clinical drug trials

The expiry date (use-by date, period of use) can be changed by a written commission of the sponsor. According to the Fimea regulation 8/2019 the expiry date information can be changed at the clinical trial site on label of the IMP available at the site, when justified from the point of view of the quality of the IMP and continuation of the trial. The change of expiry date on the package label does not have to be notified to Fimea.

Principles of GMP as stated in GMP Annex 13 have to be followed also when the expiry date labeling change is done at the clinical trial site. In other words, the labeling change has to be appropriately instructed and documented, and the person doing the labeling update (e.g. monitor or study coordinator) has to be appropriately trained in principles of GMP relevant for labeling. It must be ensured, that in the facilities where the operation is made, there is no risk for mix up of the IMPs and that possible storage conditions are appropriately taken into consideration.

3 Nov 2021

Investigational medicinal product (IMP) package labeling should comply with the Fimea regulation 8/2019 before release for use in a clinical trial.

Certain label details required by the regulation can in accordance with GMP Annex 13 be omitted, if justified according. In this case, it should be ensured that the information is available by other means, e.g. in a study card given to the participant or in an electronic system. These exceptions should not endanger the traceability of the IMP or the safety of the trial participants.

According to the Fimea regulation 8/2019 when IMP is dispensed, information about the participant or study visit may be added to the package label, but in a way that does not obscure the original label text. Entries added at the time of IMP dispensing may include e.g. details of the participant, visit number or additional instructions for use, and they can be done by the investigator or a delegated study team member (e.g. a study nurse) who has been appropriately trained.

3 Nov 2021

PASS study may be required by the authority or carried out of the marketing authorization holder’s own iniative. PASS may be interventional or non-interventional trial. Interventional trials are subject to notification process as detailed in the Reg. 8-2019 for clinical trials. Fimea is not required to notify of the non-interventional PASS study carried out of the marketing authorization holder’s own initiative. However if the PASS study was required by Fimea, it has to be notified to Fimea even in the case of a non-interventional study.

Related Assets:
Täytyykö myyntiluvan myöntämisen jälkeiset turvallisuustutkimukset eli ns. PASS-tutkimukset ilmoittaa Fimealle?

19 Jan 2021

VHP is a Voluntary Harmonisation Procedure applied to multinational clinical drug trials conducted in EU Member States. Finland is also participating into VHP processes. Parties willing to participate in the VHP process should submit their requests to a mailbox coordinated by Paul Ehrlich Institute in Germany at [email protected].

Once the application has passed the VHP process, a national request is submitted in Finland. 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. Additional information may be requested from the documents submitted nationally to Fimea at this stage. 

8 Jan 2021

An investigational medicinal product is a pharmaceutical substance or placebo being tested or used as a reference in a clinical trial. This includes products that already have marketing authorisation in place.

In the clinical trial, investigational product may be used according to the SPC (summary of product characteristics) or according to the usual practice, and still be regarded as investigational product. 

19 Jan 2021

In the EudraCT application form, the investigational product may be defined with certain drug substance or with ATC code, if there are different trade names being used for the same drug substance in the trial. 

19 Jan 2021

No, in addition to pharmaceutical facilities and units manufacturing medicinal substances for the purpose of clinical drug trials, investigational medicinal products can be produced in hospital pharmacies, medicines dispensaries, pharmacies or branch pharmacies. They must notify the Finnish Medicines Agency (Fimea) of their intention to manufacture prior to commencing production. The notification must include details of the relevant medicinal products, form, research project identifier, an estimate of the production volume and a statement on the quality control and release mechanisms.

10 Nov 2015

Clinical trials involving medicinal products for gene therapy, somatic or xenogeneic cell therapy or medicinal products containing genetically modified organisms, written authorization from Fimea is required before such clinical trial can commence. The amount of payment for an application is 3300 € according to the Ministry of Social Affairs and Health. The processing time for the application is 90 days.

Other clinical trials i.e. trials involving chemical or biological medicinal products, are subject to notification process. If no clarification is requested, the trial may commence without specific permission from Fimea when 60 days have elapsed from commencement of the processing. The amount of payment for a clinical trial notification is 3000 €.

A waiver of processing fee may be requested in respect of a notification
relating to a clinical trial on a medicinal product conducted without outside financing or with financing by a non-profit corporation. For more information, please see Administrative Regulation 8-2019 for clinical trials.

19 Jan 2021

Yes. The sponsor and the person conducting the research can mutully agree on how to divide responsibility for these obligations. A short statement on the agreed arrangement should be submitted to Fimea alongside the research notification.

10 Nov 2015

Adverse reaction is any untowarded adverse event that may have been caused by the investigational drug product. Serious and unexpected adverse reactions (i.e. SUSARs) must be reported to the authority in an expedited manner. Commercial sponsors are reporting SUSARs electronically via EudraVigilance system.

Sponsors not registered to EudraVigilance (i.e. academic sponsors) should submit their expedited SUSAR reports to Fimea, if SUSAR is originating from Finland. Reports should be sent electronically using Fimea secured email to the address FI-CTA (a) fimea.fi

19 Jan 2021

The new documents should be accompanied with the track change versions of the updated documents. When necessary, the updated version of the EudraCT-form, the Substantial Amendment form and/or the End of the Trial-form should also be submitted.

Please remember to add cover letter, and to specify  therein:

• what clinical trial is this submission for (Klnro, EudraCT number)?
• the content of the submission (appendices)
• is the substantial amendment in question
• are the same documents being submitted or have they been submitted before for any other clinical trial(s) (if yes, please specify into which trial(s)
• the details for the contact person
• if there are other issues concerning evaluation or if evaluation is needed urgently 

Fimea is to be notified of substantial amendments only, for the definition please see the Reg. 8-2019 for the clinical trials.

19 Jan 2021

Once a year, the sponsor must provide Fimea with a list of all suspected serious adverse reactions which have occurred during the period in question. The list should be accompanied by a short statement on the safety of the research subjects (section 10g of the Medical Research Act, as amended in Act 295/2004).

The DSUR Executive Summary or section 3.18 will not replace the brief report of the safety of the persons participating in the clinical trial because the focus of the sections. The brief report should be about the safety of the trial patients from the view of the clinical trial, taking into consideration all aspects of the clinical trial, not only the safety of the IMP. There are no detailed guidance of the format or the author of the report, but the author can be a person with medical education, for example the person in charge of the trial in Finland, the primary investigator or the medical adviser of the sponsor.

During the CTR (Clinical Trials Regulation (EU) 536/2014) transitional period of 31 January 2022 to 31 January 2025, please see further instructions from our website.

8 Mar 2022

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. The report should be submitted in the form of a summary, a synopsis, published article or in some other similar way.

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. Results of prematurely ended trials, or if ended before 21.7.2013 and carried out with adult participants can be posted in EudraCT in the form of pdf document. More information about modalities can be found here.

Please see EudraCT´s homepage on posting and publication of results-related information on clinical trials.

9 Nov 2021

Submissions for Clinical Trials Unit Fimea should be made electronically to the common mailbox FI-CTA (a) fimea.fi. The documents should be in PDF format (except EudraCT .xml-files).

For the secured electronic mail, CESP, Eudralink or Fimea’s secure mail service (especially for academic sponsors) may be used. 

For additional information, please visit here.

19 Jan 2021