Publications

EANM EU-related publications

 

This statement provides basic information about Nuclear Medicine, its specificities and current most urgent policy needs. Focussing on the policy as of today, and building on Europe’s Beating Cancer Plan and the SAMIRA Action Plan, the statement aims at offering all stakeholders, at the European or national level, a better understanding of the specificities of the Nuclear Medicine sector.

 

The last few years have seen important changes in the development and composition of radiopharmaceuticals introduced in clinical practice. These technical changes have led to new delivery requirements: nowadays, posologies need to be more patient-centric. However, EU requirements for the use of radiopharmaceuticals in patients, based on their respective posologies, which are issued as part of their marketing authorization by the European Medicine Agency (EMA), are currently not fitting the needs and are partially in contradiction to the Council Directive 2013/59/Euratom, which leads to complex situations in clinical practice.

 

In the context of the upcoming review of the European Pharmaceutical Legislation (Directive 2001/83 EC), this statement has been written by members of the EANM Radiopharmacy Committee and the EANM Board and is intended to provide input for the consideration of specificities of Radiopharmaceuticals within this review. The document addresses current regulatory challenges, aiming at ensuring the quality and safety of radiopharmaceuticals as well as a harmonised framework and efficient supply chains.

 

As part of the EU pharmaceuticals strategy, and drawing lessons from the COVID-19 pandemic, the European Commission plans to evaluate and revise the EU’s general legislation on medicines for human use to ensure a future-proof and crisis-resistant medicines regulatory system. Legal proposals to review Directive 2001/83/EC and Regulation EC/726/2004 are to be expected for the end of 2022. The EANM’s main points of concern have been summarised in a briefing paper.

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