Prior notice of a clinical trial on pharmaceuticals
- Permit or other obligation
- Public service
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
Do the following
A clinical trial is reported according to the instructions on Fimea's website. The notice form available on the EudraCT database website is used.
Notification of a clinical trial - EudraCT:
-Apply for a EudraCT number
-Fill in and save the notification form as .xml format
-The form in .xml format should be submitted electronically to Fimea together with a signed PDF
Applying for a EudraCT number:
Apply first for a EudraCT number on the EudraCT website (Create -> EudraCT Number). The applicant shall fill in all compulsory fields marked with an asterisk. The EudraCT number will be sent to the applicant in an e-mail message. The same EudraCT number shall be used for multinational multicenter studies in all countries.
Filling in the EudraCT notification form:
Once the EudraCT number has been provided for the trial, the applicant shall fill in a notification form on the EudraCT website (Create -> Clinical Trial Protocol -> EEA CTA). Instructions on how to fill in the notification form are available on the EudraCT website.
The form may be completed in Finnish, Swedish or English.
After checking the information, the Agency shall submit the EudraCT file to the official EudraCT database.
Notification of substantial protocol amendments and of study completion
When substantial amendments to the protocol are made, a Notification of Amendment form, available on the European Commission website, should be filled in; another form (Declaration of the end of a Clinical Trial) should be filled in at study completion.
To whom and on what terms
In unclear cases, Fimea decides whether an advance notice of a clinical pharmaceutical trial should be made. A multi-centre study is considered to be a single study with an obligation to submit one complete report.
Where medicinal products containing genetically modified organisms are used in a clinical trial, their use must be notified in advance or submitted to the Board for Gene Technology.
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. Results of prematurely ended trials can be posted in EudraCT in the form of pdf document.
Please see EudraCT´s homepage on posting and publication of results-related information on clinical trials.
For more information, see: Medicines Act (395/1987), Medical Research Act (488/1999) and Fimea Regulation 8/2019: Clinical trials.
A fee is charged for the service.
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)