Activities in the EU and the rest of the world

16 April 2019

The Danish Medicines Agency’s vision is to become one of Europe’s best in class, and we work to develop the area of medicines and medical devices both in the EU and the rest of the world. We do this to ensure that effective medicines and medical devices, by means of the latest knowledge and technology, are made accessible to those who need them.

The medicines and medical devices areas are based in particular on European legislation and close and effective collaboration in the EU where the EU countries pool their competencies in relation to, for example, medicines licensing as well as share knowledge and acknowledge each other’s inspections and laboratory controls, etc.

The Danish Medicines Agency thus participates in numerous European and international networks and forums to influence the development within the politically adopted frameworks. The European and international collaboration strengthens and expands our own expertise within different disciplines, which is vital for our national regulatory work.

Strong positioning in the international collaboration between authorities

Especially in EU matters, we play an active role in terms of supporting and taking part in joint European work that involves medicines and medical devices.

On the international stage, the Danish Medicines Agency has entered into strategic sector cooperation agreements with China and Brazil.

We have also established cooperation agreements with the drug regulatory authorities in the USA and Japan – particularly with the intention of acquiring knowledge in areas where these players hold strong positions. These cooperation agreements support our ambition of reaching European and international excellence.

EU

Especially four European entities work with the regulation of medicines and medical devices in the EU. They are:

  • The European Commission
  • The European Medicines Agency (EMA)
  • The Heads of Medicines Agencies (HMA) – a network for the national drug regulatory authorities in the EU/EEA
  • The Competent Authorities for Medical Devices (CAMD) – a network for the national drug regulatory authorities in the EU/EEA that are responsible for activities related to medical devices

All of these entities cooperate closely so they can allocate resources from across the EU to the regulatory processes. In this setup, the EU has access to thousands of experts from the national authorities, helping to ensure that the regulation of medicines and medical devices meets high standards at all times.

The Danish Medicines Agency is an active player in this work.

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