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| | LIFE SCIENCE NEWS
In this edition of DELACOUR’s Life Science newsletter you can read about important news for the pharmaceutical industry in Denmark and the EU - including a new regime for fast tracking approval of new medicines in the EU, transparency on clinical data, and a possible new way of prioritizing the use of medicines in Denmark. | |
Best regards
DELACOUR |
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| | | | | | EMA launches new scheme PRIME for medicines that target unmet medical needs | On 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. | | |
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| | | | | | | The Danish Regions’ plan for prioritizing medicine expenditure | | At 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.
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| | | | | Extension of ENLI’s authority | |
As 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.
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| | | | | | | News from the EU on transparency of clinical data | | The European Medicines Agency (EMA) publishes guidance on EMA policy on the publication of clinical data.
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| | | | | Interested in more Life Science news? | | Sign up for our Life Science & Healthcare newsletter.
Send an e-mail to hvm@delacour.dk with your name, e-mail address and company name. |
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| | | The DELACOUR Life Science team is dedicated to assisting international and Danish clients on the Nordic markets within pharma, biotech, medical devices, food and dietary supplements.
Our legal work for the life sciences industries is deeply rooted in experience and understanding of these highly regulated industries. Clients appreciate DELACOUR's ability to work across traditional legal disciplines to provide 360 degrees’ advice based on understanding of the challenges facing life science businesses in Europe. |
| | | Legal notice & Disclaimer
All information in DELACOUR DANIA's newsletter is intended as a service and for general informational purposes only and may not be considered as or substituted for any advice. DELACOUR DANIA cannot be held responsible for the content of the letter or for the acts of a reader on the basis hereof. Text and pictures in the newsletter are protected by the copyright laws of the Kingdom of Denmark. Unless it is specifically stated that the content hereof may be downloaded, any storage, copying or retransmission is prohibited without the prior written consent of DELACOUR DANIA. |
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