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EANM-NMEU joint communication on the European Pharmaceutical Legislation revision: Turning the tide – A Critical Call for Unlocking Nuclear Medicine Potential in Europe
In the context of the revision of the EU Pharmaceutical Legislation, it is with great regret that the European Association of Nuclear Medicine (EANM) and Nuclear Medicine Europe (NMEU) see that the recommendations of their joint proposals were not included in the final position of the European Parliament. Our concern is that the regulatory framework for radiopharmaceuticals is not well served by the final position, which means that Europe is unlikely to be at the forefront of advances in radiopharmaceuticals in the future and modern radiopharmaceuticals will continue to struggle with the existing regulatory framework. Now that the focus shifts to the Council of the EU, this statement is a call to policymakers to reconsider radiopharmaceuticals developments.
April 29, 2024
EANM Statement on the Union List of Critical Medicines Rationale for inclusion of radioisotopes
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
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.
Joint statement of the EANM and NMEU on the revision of the EU Pharmaceutical Legislation – Time to Act for Nuclear Medicine
The new EU Pharmaceutical Package includes very important legislations for the future of healthcare in Europe. In this respect, the European Association of Nuclear Medicine (EANM) and Nuclear Medicine Europe (NMEU) have joint forces to highlight the specific aspects that touch on Nuclear Medicine.
The EANM Statement on Animal Testing in the EU: the potential adverse effect of a ban on biomedical research
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.
The QuADRANT study: current status and recommendations for improving uptake and implementation of clinical audit of medical radiological procedures in Europe—the nuclear medicine perspective
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).
Joint Statement of the EAHP and the EANM on the availability of radiopharmaceuticals in the context of the revision of the general pharmaceutical legislation
In the context of the revision of the general Pharmaceutical Legislation, this joint statement of the European Association of Nuclear Medicine (EANM) and the European Association of Hospital Pharmacists (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
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.
EANM Statement: Posology for Radiopharmaceuticals: contradictory legal requirements between BSS Directive 2013/59/Euratom and EMA marketing authorisations schemes
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.
EANM Statement for a better inclusion of the particularities of Radiopharmaceuticals within the Review of Directive 2001/83EC on Pharmaceutical Legislation
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.