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
Compassionate Use
To a group of patients
A new Guideline will be published at the end of Q2. In the meantime, please read more about this at EMA.
On a single patient basis
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).
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: 15.06.2010
Første gang publisert: 26.06.2002