EMA launches new scheme PRIME for medicines that target unmet medical needs
09.03.2016On 4 March 2016, the European Medicines Agency (EMA) launched PRIME (PRIority MEdicines), a priority scheme to support medicinal products benefiting patients with no treatment options or offering a significant therapeutic advantage over existing treatments.
News from the EU on transparency of clinical data
09.03.2016The European Medicines Agency (EMA) publishes guidance on EMA policy on the publication of clinical data.
Extension of ENLI’s authority
09.03.2016As of 1 February 2016, the Danish Ethical Committee for the Pharmaceutical Industry (ENLI) has been given authority to control and impose sanctions on pharmaceutical companies that do not comply with the regulations pertaining to the clinical testing of pharmaceuticals and non-interventional studies.
The Danish Regions’ plan for prioritizing medicine expenditure
09.03.2016At a press conference on 5 February 2016, the Danish Regions presented their new model for the assessment of medicine. As part of the implementation of the new model, a new prioritization structure will be established and this will likely be named the Medicine Committee.