International influence

The legislation in the area of medicines and medical devices is European, and we collaborate to a great extent with other countries on matters of authorisation, control, reimbursement, supply and much more. It is therefore essential that we focus on international involvement and collaboration. By doing so, we may ensure high-standard and harmonised administrative processes in the EU while asserting Danish influence on the regulatory framework being discussed and developed in the EU and in other international forums. The Danish Medicines Agency’s international involvement moreover has a major impact on the Danish life sciences ecosystem and on patient safety.

At the European level, we will focus on our activities in various committees, working groups and coordination groups, including in the European Commission, EMA, CAMD and the HMA so that we can follow and influence the development of the regulatory framework for medicines and medical devices. Wherever possible, we will take a key role in European collaboration. Wherever relevant, for example in relation to the Danish Medicines Agency’s strategic or tactical focus, we will stay up to date with any new emerging areas and where our participation may be wanted or needed.

Pharmaceutical development, medical devices, distribution and supply are becoming increasingly global concerns. To the extent possible, we will therefore take part in global collaborations, such as ICH and ICMRA, and thus strengthen the global working arrangements with other authorities to ensure efficient knowledge sharing and Danish influence.

In 2024, the Danish government presented a new Life Science Strategy, taking forward the ambition for Danish health authorities, including the Danish Medicines Agency, to prioritise bilateral working arrangements with other authorities in selected OECD countries. Also in 2024, the Danish Medicines Agency fulfilled a strategic agency objective by compiling a list of all international groups in which its employees are represented. This list will be updated regularly and will categorise the various groups’ strategic importance for the Danish Medicines Agency.

We will let this benchmark guide us towards fulfilling the following two focus areas in 2026:

• We exert decisive influence on European collaboration
• We enter bilateral collaborations that are beneficial

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