News about Licensing and supervision
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Good progress in Denmark-China collaboration
| 01 July 2019 |
The Danish Medicines Agency’s collaboration with the Chinese drug regulatory authorities has entered a new phase, reaching agreement on specific collaboration projects among which a project on quality control of radiopharmaceuticals.
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End of day meeting on new EU recommendations on complex clinical trials at the Danish Medicines Agency
| 29 March 2019 |
The Danish Medicines Agency invites pharmaceutical companies, researchers and other interested parties to an end of day meeting on the new European recommendations on complex clinical trials which aim to support the development of personalised medicine.
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Public consultation on electronic package leaflets and summaries of product characteristics across the EU
| 12 March 2019 |
What should the package leaflets and labels of medicines for citizens and the summaries of product characteristics for healthcare professionals look like in the future? A public consultation on key principles about this has been launched throughout the EU, with comments to be submitted by 31 July.
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Common European recommendations establish a framework for testing medicines of the future
| 08 March 2019 |
The common European subgroup for complex clinical trials with trial subjects, which is headed by Denmark, has just published a set of recommendations for the development of personalised medicine.
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New EU report on big data paves the way for action
| 01 March 2019 |
A taskforce on big data in the pharmaceutical area, the HMA-EMA Joint Big Data Taskforce, has just published its first report. The report offers a definition of big data and several recommendations for European authorities that regulate medicines and medical devices.
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New data analysis centre to open at the Danish Medicines Agency
| 08 February 2019 |
The Danish government today announced its decision to support the establishment of a new data analysis centre in the Danish Medicines Agency. The centre is to handle the analysis of large data quantities in the pharmaceutical and medical devices areas and will set new standards for the monitoring of the safety and efficacy of medicines and medical devices after their marketing.
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Updating of summaries of product characteristics due to changed ATC codes for 2019
| 18 January 2019 |
Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2019.