EANM EU-related publications
- EANM Statement on the Union List of Critical Medicines Rationale for inclusion of radioisotopes (February 2024)
Following the publication of the Union List of Critical Medicines, this paper outlines the importance of including medical radioisotopes in this list to facilitate the mitigation of radioisotope shortages across Europe.
- The revision of the pharmaceutical legislation – it is time to act for nuclear medicine in Europe (October 2023)
Amid the reform of the European Union Pharmaceutical Framework, the EANM has conducted significant advocacy efforts to bring nuclear medicine to the attention of EU decision-makers.
Our latest article published in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) highlights how critical changes in the EU Pharmaceutical Framework impact the field of nuclear medicine, driving innovation and patient care in the EU.
The new EU Pharmaceutical Package includes very important legislations for the future of healthcare in Europe. In this respect, EANM and NMEU have joint forces to highlight the specific aspects that touch on Nuclear Medicine.
In the context of the European Citizen’s Initiative (ECI) ‘Save Cruelty Free Cosmetics – Commit to a Europe without animal testing’, the EANM draws attention to the detrimental aspects of the above-mentioned petition and to the serious consequences that a general ban on animal experiments could have on healthcare in the EU.
This article highlights the results of the QuADRANT project, a comprehensive study focusing on improving clinical audits in the field of nuclear medicine. The project examined the current state of clinical audit implementation in the EU27+4, identifying good practices and available resources. It aims to provide guidance for enhancing the uptake and implementation of clinical audits in disciplines involving ionising radiation. The main findings have been summarised in this publication of the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI).
In the context of the revision of the general Pharmaceutical Legislation, this joint statement of the EANM and the EAHP focuses on the need for a flexible regulatory framework for low-volume products. This paper explains how the revision of the Pharmaceutical Legislation could reduce the regulatory burden for small-scale preparations by clearly distinguishing between commercial and non-commercial preparations of medical products, notably on marketing authorisation procedures.
- EANM Overarching Narrative (June 2022)
This statement provides basic information about Nuclear Medicine, its specificities and the 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 authorisation 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 expected by the end of 2022. The EANM’s main points of concern have been summarised in a briefing paper.