UPDATE: No votes for the Danish Medicines Agency or the Danish Health Authority
05.12.2016When the new Medicine Committee will start operating in 2017 there will be no voting rights for the Danish Medicines Agency (DMA) or the Danish Health Authority (DHA) when it comes to the decision-making on prioritizing medicines. Further, there will be no complaints board or appeal option.
Revision of EMA’s guideline on first-in-human clinical trials: Open for public consultation
05.12.2016To further improve safety of trial participants, the European Medicines Agency (EMA) has in cooperation with the European Commission and the EU Member States changes to the existing guideline on first-in-human clinical trials.
UPDATE: The European Medicines Agency provides public access to clinical reports
05.12.2016Following DELACOUR’s newsletter of March 2016, in which EMA’s policy on publication of clinical data was the topic, the European Medicines Agency (EMA) has made its new database available to the public containing data from various clinical trials.