Better conditions for clinical trials in Denmark
The Danish government, the Danish People's Party and the Danish Social-Liberal Party have agreed to exempt commercial sponsors from all fees for phase I clinical trials of medicines. This is done as part of the Growth Plan for Life Science and to strengthen research in general. The change is effective from 1 July 2018 and means that commercial sponsors of phase I clinical trials will no longer have to pay for applications to start trials, make substantial changes or pay annual fees.
The government has previously decided – in connection with the Budget Bill 2018 – to remove the Danish Medicines Agency’s fees for non-commercial (research-initiated) clinical trials of medicines. This means that non-commercial sponsors of clinical trials will neither have to pay a fee for authorisation to start a clinical trial, making substantial amendments nor to pay annual fees.
The fee changes will generally improve the framework conditions for clinical trials in Denmark. Read more about clinical trials of medicines.
The sponsor is the person, company or institution assuming the responsibility for the initiation, management and possibly the financing of a clinical trial. Clinical trials are conducted to test a particular medicine in human beings to find out how it works, what side effects it causes and how it is metabolised in the body.