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HomeSAMIRA study on the implementation of the Euratom and EU legal bases with respect to the therapeutic uses of radiopharmaceuticals
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While the use of radiopharmaceuticals is paving the way towards a new paradigm especially in cancer care and towards personalised medicine for many diseases and medical conditions, challenges to ensure and maintain high standards for the quality and safety of nuclear medicine treatments are increasing. Some of these challenges relate to the complex regulatory framework regulating the preparation and use of radiopharmaceuticals in general and therapeutic radiopharmaceuticals specifically. Nuclear medicine is a multidisciplinary specialty that involves the administration of radioactive substances in order to diagnose and treat disease in patients of every age group. Each year more than 10 million patients in Europe benefit from nuclear medicine studies relating to cancer, cardiovascular, neurovascular and endocrine diseases. Currently over 100 different nuclear medicine procedures are approved worldwide by regulators. Therapeutic as well as diagnostic nuclear medicine applications have demonstrated an excellent clinical safety profile. Given their chemical, physical and clinical particularities, however, radiopharmaceuticals are a very special class of drugs that require specific considerations. As such, their preparation, handling and use are regulated in two separate legal frameworks. Specifically, medicinal authorisation and supervision are laid out in the EU’s pharmaceutical legislation, while radiation safety is regulated under Euratom radiation protection legislation. Additional complexity is added by the fact that nuclear medicine is a highly innovative and rapidly developing field of medicine. The 24-month SIMPLERAD project aimed to improve the understanding of the links and interdependencies between the European pharmaceutical legislations and Euratom radiation protection requirements and highlight potential barriers to coherent implementation of radiopharmaceutical therapies in clinical practice. It proposes practical guidance and recommendations to advance a coherent implementation of these requirements and inter-linkage with respect to the therapeutic use of radiopharmaceuticals. The study further explores quality and radiation safety issues related to the current use and introduction of novel therapeutic radiopharmaceuticals into clinical practice, the role of medical physics experts, requirements for dosimetry, release of patients from hospital, and management of radioactive waste.
- Published:
- Corporate author(s): Directorate-General for Energy (European Commission)
- Personal author(s): Krause, B.J ; Lassmann, M ; Bardiès, M ; Gear, J ; Verburg, F.A ; Covens, P ; Decristoforo, C ; Herrmann, K ; Patt, M ; Peters, S ; Schulze, R ; Stokke, C ; Hierath, M ; Peld, N.D
- Themes: Nuclear energy and safety
- Subject: EU study report , health control , health legislation , ionising radiation , medical diagnosis , nuclear medicine , pharmaceutical legislation , radiation protection , safety standard , scientific cooperation , therapeutics
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| ISSN | ISBN 978-92-68-26298-6 | DOI 10.2833/1710575 | Catalogue number MJ-01-25-088-EN-N |
- Released on EU publications website:
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