News from the Danish Medicines Agency
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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.
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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.
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Union Product Database: Deadlines for the Submission of Annual Volume of Sales data for veterinary medicinal products
According to Article 58(12) of Regulation (EU) 2019/6 , all Marketing Authorisation Holders must submit the annual Volume of Sales for each veterinary medicinal product to the Union Product Datab
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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.
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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.
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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.