A clinical trial is a systematic investigation of a medicinal product intended to gather or confirm knowledge on efficacy, interaction, adverse reaction and pharmacokinetics or investigate its medicinal value.
Regulation. 443/2004 on clinical trials, which came into force in May 2004, implements Directive 2001/20/EC as well as Directive 2001/83/EC on medicinal products for humans. Directive 2001/20/EC applies to all of the European Economic Area (EEA) and guidelines on the European Commission website (EudraLex – Volume 10 Clinical trials guidlines) apply in Iceland as well as in the other EEA countries.
Clinical trials must be approved by IMA
The sponsor (person/company) always needs to apply to IMA for the conduct of a clinical trial. A principal investigator must always participate in the conduct of the trial. IMA evaluates the quality of the investigation and investigational medicinal product and the overall safety of participants in clinical trials.
Before a clinical trial can be started, approvals have to be obtained from IMA and the National Bioethics Committee.
The following items should be considered when applying
- The Regulation does not apply to non-interventional investigation
- The Regulation covers bioavailability and bioequivalence studies
- The Regulation applies to radioactive medicines, natural medicines, homeopathic medicines, medicines for gene-therapy or for remedy with body cells and medicines, which contain genetically modified organisms
- All medicines (substances/products) to be investigated must be manufactured according to the principles of Good Manufacturing Practice (GMP)
The Helsinki Declaration from 1996 must be observed on the protection on individuals unable to give informed consent, surveillance of adverse effects etc.
The Icelandic Medicines Agency (IMA) sends an invoice to the respective applicant when the application has been received, unless specified differently in the application. The fee must be paid prior to confirmation of the clinical trial application. The fee for a clinical trial is in accordance with the current IMA tariff