Clinical Drug Trials
The Finnish Medicines Agency, 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:
- they involve normal patient care which does not differ from normal treatment practice;
- there is no additional intervention due to the investigation;
- no extra diagnostic or other monitoring methods are applied to the trial subjects, and the data are collected from information obtained from normal care;
- the medicinal products are prescribed in the normal manner, in accordance with established treatment practice;
- the decision to prescribe the medication is totally independent of the decision to
- include the patient in the trial;
- the trial protocol does not define in advance the patient’s specific treatment and choice of medication,
- epidemiological methods are used to analyse the data.
In the case of any uncertainty, Fimea will decide whether a notification for a clinical trial on medicinal products should be submitted.
Payments
The amount of payment for a clinical trial notification is 2200 €.
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 2500 € according to the Ministry of Social Affairs and Health.
Payment must be made to the Finnish Medicines Agency's account Sampo Oyj 800014-21979.
Further information:
Esko Nuotto, Head of Unit
Eija Mikkonen, Clinical Trials Coordinator
Paula Koivumäki, Clinical Trials Coordinator
Anu Puomila, Senior Researcher
Ilpo Lundberg, Clinical Trials Coordinator
E-mail addresses firstname.lastname@fimea.fi.
Updated 1.2.2010