News from the Danish Medicines Agency
Better conditions for clinical trials in Denmark
| 03 May 2018 |
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. 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.
Danish-Japanese collaboration on better use of health data
| 02 May 2018 |
The Danish Medicines Agency met today with leading representatives from the Japanese Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency at the Danish Medicines Agency in Copenhagen. The purpose of the meeting was to exchange knowledge and experience regarding regulatory work in the pharmaceutical area, and to begin a broader collaboration between the agencies.
What is medicinal cannabis?
| 12 April 2018 |
The Danish Medicines Agency has produced a short infographic film illustrating the different types of medicinal cannabis.
DKMA Update March 2018
| 28 March 2018 |
In this issue of DKMA Update you can read about evidence; changes to Tramadol’s summary of product characteristics; inspections of the sale of OTC medicines outside pharmacies and much more
New concept for national scientific advice
| 22 March 2018 |
The Danish Medicines Agency will soon launch a new national scientific advice concept for companies, hospital researchers and others who require advice on requirements for marketing authorisations or clinical trials.
Infographic on the medicinal cannabis pilot programme
| 21 March 2018 |
The Danish Medicines Agency has produced a short infographic film about the medicinal cannabis pilot programme. The film gives a brief introduction to the programme and is intended for sharing on social media.
New funds for accumulation of knowledge about medicinal cannabis
| 20 March 2018 |
The parties negotiating the special funds have earmarked a further DKK 5 million to increase knowledge about the use and effect of medicinal cannabis. You can apply for the funds now.
Be aware of rare but possible risk of liver injury in medical treatment of fibroids
| 15 February 2018 |
The Danish Medicines Agency recommends doctors not to start any new patients on the medicine Esmya (ulipristal) because of a rare, but possible, risk of developing serious liver injury.
COVID-19: Restriction on OTC medicines lifted
The Danish Medicines Agency lifts the restriction on over-the-counter (OTC), which has been in force since March. This means that pharmacies, supermarkets, kiosks and others with permission to sell OTC medicines can resume selling more than one pack of the same type of OTC medicine per customer.
Danish Medicines Agency shortens the review time for applications for COVID-19 medicine trials
Drug regulatory authorities around the world are taking several steps to speed up the development and availability of medicines to treat and prevent novel COVID-19. The Danish Medicines Agency in Denmark has just implemented an emergency procedure for applications for clinical trials with human subjects.
Thomas Senderovitz leaves the Danish Medicines Agency
Thomas Senderovitz has announced that he is leaving his role as Director General of the Danish Medicines Agency to pursue fresh opportunities.
New EU rules on falsified medicines
When new EU rules enter into force on 9 February 2019, it will be harder for falsified medicines to reach patients in the EU. The new rules, which introduce new safety features on the packaging of medicines and other measures, are to prevent falsified medicines from entering the legal supply chain of medicines – for example in pharmacies and hospitals.
New report: Evaluation of the relationship reform
The framework for collaboration between healthcare professionals and companies has just been evaluated. The evaluation concluded that the rules and administration work well, but compliance with the rules lags behind. There is a need for more information to healthcare professionals about the rules.
EMA: No evidence linking ibuprofen to worsening of COVID-19
The press and social media have raised questions about whether ibuprofen could worsen the condition of patients infected with COVID-19. The European Medicines Agency reports that there is currently no scientific evidence to suggest this. The Data Analytics Center of the Danish Medicines Agency now launches an ultra-quick study.