Prior to initiating and implementing a clinical trial in Denmark, authorisation from relevant public authorities must be obtained. Applications relating to a clinical trial must be submitted to the Danish Health and Medicines Authority and a Regional Committe on Health Research Ethics (clinical trials concerning particularly complex areas for instance trials with Advanced Therapy Medicinal Products (ATMP) must be submitted to the National Research Ethics Committee (DNVK)).
Danish Health and Medicines Authority
The Danish Health and Medicines Authority is the supreme health and pharmaceutical authority in Denmark. The authority is responsible for approving clinical trials to be carried out in Denmark. Applications for approval of new trials must be finalized within 60 days, but the Danish Health and Medicines Authority is aiming for processing the first response to sponsor to be completed within a maximum of 30 working days. Average processing time until first response during the first half of 2015 was 36 working days. Assessment times are published on the Danish Health and Medicines Authoritys website on a monthly basis.
- Clinical trials of medicines in humans
- Guideline for applications for authorisation of clinical trials of medicinal products in humans
- Assessment times for clinical trial applications
Regional Committees on Health Research Ethics
Since 1980 Denmark has had a health research ethics committee system working to safeguard the currency and efficiency of Danish health research ethics. The system consists of 11 Regional Committees on Health Research Ethics and one National Committee. The purpose is to make sure, that research projects - from a research ethical point of view - are carried out in a responsible manner, including the protection of rights, safety and wellbeing of trial subjects participating in biomedical research projects.
According to Danish law, all research projects in Denmark involving human beings or any kind of human tissue, cells etc. need prior permission from a regional committee. Thus, before commencing a clinical trial in Denmark, authorization must be obtained from a regional ethics committee on health research ethics (some specific types of trials, e.g. ATMP, must be submitted directly to the national comittee).
Applications for approval of new trials must be processed within 60 days. In 2014, the 11 regional ethics committees processed 1.356 new applications on scientific research projects (of which 20 per cent involved clinical trials). Approximately 90 per cent of all applications were processed within relevant deadlines.
Decisions from the regional comittees may be appealed to the National Committe on Health Research Ethics, which also handles particularly complex issues. In relation to Denmark's implementation of EU's new Clinical Trials Regulation (EU 536/2014), the national comittee is expected to attain a more prominent role in authorizing clinical trials in Denmark in the future.
Danish Data Protection Agency
Apart from attaining explict permission from the authorities mentioned above, a clinical trial must - prior to being initiated - must be compliant with relevant provisions in the Act on Processing of Personal Data, which became effective from July 1st, 2000. The Act contains specific provisions concerning the use of sensitive personal information in relation to e.g. clinical trials in Denmark involving pharmaceuticals, medical devices etc. The Danish Data Protection Agency supervises compliance of the Act on Processing of Personal Data.
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