Clinical trials
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 guideline to the regulation has been revised, and a new vervion was published on September 8 2011. Unfortunately, an English version is currently not available.
Temporary change in practice related to answering submissions of substantial amendments
The Norwegian medicines Agency (NoMA) will, due to temporary lack of resources, change our practice related to answering submissions of substantial amendments. If the Ethics Committee has approved the application, and the Norwegian Medicines Agency does not oppose amendments within 35 days of receiving a valid application, the sponsor may implement the changes (according to the Norwegian regulation for clinical trials of 30-10-2009, § 5-1). This provisional change came into force on February 2 2011 and will apply until a message is published on our web page.
NoMA has until recently responded to all applications for substantial amendments on clinical trials and approved or denied these. However, due to lack of resources and increasing backlogs, we have decided to temporarily change our practice from February 2. From that day the procedure will be as follows:
- Substantial amendments shall still be submitted to the NoMA.
- If the Ethics Committee has approved the application, and the Norwegian Medicines Agency does not oppose amendments within 35 days of receiving a valid application, sponsor may implement the changes. The substantial amendment is considered approved if the NoMA has not responded within 35 days.
- Day 0 is considered to be the day after the amendment is submitted (by regular mail or by e-mail) to the NoMA.
- An invoice will be sent to the Sponsor only in the cases when the NoMA returns a written response to the request for a substantial amendment.
- This practice will be in force until a new message is published on NoMA´s website.
Questions regarding this practice may be directed to:
Ingvild Aaløkken
Head of section,
Preclinical assessment and clinical trials
22 89 75 65
Ingvild.aalokken(at)legemiddelverket.no
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 the EMA website.
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). Download 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 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: 09.11.2011
Første gang publisert: 26.06.2002