Clinical trials
Definition
A Clinical Trial is any systematic investigation of medicinal products for human use for the purpose of acquiring or testing knowledge of the effects or influence of the products on physiological function, interactions, adverse reactions, absorption, distribution, metabolism and secretion, or to study their therapeutic value.
Regulations
Clinical Trials are mainly regulated by international and national laws and the European
Directive 2001/20/EC, wich is fully implemented in the Norwegian Regulation relating to clinical trials on medicinal products for human use, of 30. October 2009. The English version of this regulation will be published in Q1 2010. Until then, the regulation is only available in Norwegian. We are sorry for the inconvenience this may cause.
The requirements for using medicines on a compassionate basis in Norway:
- If the drug to be used has a marketing authorization in any other European country or in the Northern America (USA/Canada) the drug may be prescribed by a physician or dentist (as applicable) for the individual patient(s) as needed. The physician (or dentist) must give reason for the use of the not marketed drug in Norway and sign the application. There is a special form to be used for this purpose ("Resept/rekvisisjon for legemiddel uten markedsføringstillatelse" (Excemption from registration)). The form is available from the local pharmacy or may be down loaded from our web site (form).
- If the drug in question does not have a marketing authorization in any European country or in the Northern America (USA/Canada); i.e. the drug is still under clinical trial development/investigation, the use of the product must be notified to the Norwegian Medicines Agency in accordance with the Regulations concerning clinical trials of drugs for human beings of 24 September 2003 (in force from 1 May 2004. Directive 2001/20/EC has been fully implemented in Norway by 1 May 2004). The Regulations are also in force when it comes to compassionate use protocols. However, the Regulations does not apply to non-interventional trials.
Trials not applicable to the Norwegian Medicines Agency (NoMA):
- non-interventional trial: a study where one or more medicinal product(s) is (are) prescribed in the usual
manner in accordance with the terms of the marketing authorisation. A therapeutic strategy for each
individual patient is not decided in advance by a trial protocol, but falls within current practice, and the
prescription of the medicinal products is clearly separated from the decision to include the patient in the
study. Additional diagnostic or monitoring procedures for patients shall not be necessary and
epidemiological methods shall be used to analyse the collected data.
- A trial were a substance or a medicinal product is included without the intention to study its quality as a medicine. In these cases, it is sufficient with a favourable opinion from the Ethics committee. If there is any doubt, NoMA should be enquired.
- Clinical trials with medicinal equipment is regulated by the Directorate for Health and Social Affairs.
Clinical trials registred before 1st May 2004
Clinical trials notified before 1 May 2004 will be handled according to previous regulations. EudraCT-number is not applicable for these trials.
SUSARs however must be rapported to Eudravigilance. The trial will then be identified at protocol code and/or active substance.
Sist gjennomgått: 11.12.2009
Første gang publisert: 26.06.2002