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Regulatory

  1. Radiopharmaceuticals have been considered a special group of medicines in Europe since 1989. The use of radiopharmaceuticals that have marketing authorization should always be the first option in clinical use,...

    Authors: Estrella Moya, Celia Cerrato, Luis Miguel Bedoya and José Antonio Guerra
    Citation: EJNMMI Radiopharmacy and Chemistry 2024 9:64
    Content type: Review Published on:

  2. Nuclear medicine has made enormous progress in the past decades. However, there are still significant inequalities in patient access among different countries, which could be mitigated by improving access to a...

    Authors: Aruna Korde, Marianne Patt, Svetlana V. Selivanova, Andrew M. Scott, Rolf Hesselmann, Oliver Kiss, Natesan Ramamoorthy, Sergio Todde, Sietske M. Rubow, Luther Gwaza, Serge Lyashchenko, Jan Andersson, Brian Hockley, Ravindra Kaslival and Clemens Decristoforo
    Citation: EJNMMI Radiopharmacy and Chemistry 2024 9:2
    Content type: Position paper Published on:

  3. The development of radiopharmaceuticals requires extensive evaluation before they can be applied in a diagnostic or therapeutic setting in Nuclear Medicine. Chemical, radiochemical, and pharmaceutical paramete...

    Authors: Aruna Korde, Renata Mikolajczak, Petra Kolenc, Penelope Bouziotis, Hadis Westin, Mette Lauritzen, Michel Koole, Matthias Manfred Herth, Manuel Bardiès, Andre F. Martins, Antonio Paulo, Serge K. Lyashchenko, Sergio Todde, Sangram Nag, Efthimis Lamprou, Antero Abrunhosa…
    Citation: EJNMMI Radiopharmacy and Chemistry 2022 7:18
    Content type: Review Published on:

  4. This guideline on molar activity (Am) and specific activity (As) focusses on small molecules, peptides and macromolecules radiolabelled for diagnostic and therapeutic applications. In this guideline we describe t...

    Authors: Gert Luurtsema, Verena Pichler, Salvatore Bongarzone, Yann Seimbille, Philip Elsinga, Antony Gee and Johnny Vercouillie
    Citation: EJNMMI Radiopharmacy and Chemistry 2021 6:34
    Content type: Guideline article Published on:

  5. This guideline on current good radiopharmacy practice (cGRPP) for small-scale preparation of radiopharmaceuticals represents the view of the Radiopharmacy Committee of the European Association of Nuclear Medic...

    Authors: Nic Gillings, Olaug Hjelstuen, Jim Ballinger, Martin Behe, Clemens Decristoforo, Philip Elsinga, Valentina Ferrari, Petra Kolenc Peitl, Jacek Koziorowski, Peter Laverman, Thomas L. Mindt, Oliver Neels, Meltem Ocak, Marianne Patt and Sergio Todde
    Citation: EJNMMI Radiopharmacy and Chemistry 2021 6:8
    Content type: Guideline article Published on:

  6. To fulfil good manufacturing requirements, analytical methods for the analysis of pharmaceuticals for human and vetinary use must be validated. The International Conference on Harmonization of Technical Requir...

    Authors: Nic Gillings, Sergio Todde, Martin Behe, Clemens Decristoforo, Philip Elsinga, Valentina Ferrari, Olaug Hjelstuen, Petra Kolenc Peitl, Jacek Koziorowski, Peter Laverman, Thomas L. Mindt, Meltem Ocak and Marianne Patt
    Citation: EJNMMI Radiopharmacy and Chemistry 2020 5:7
    Content type: Guideline article Published on:

  7. The EU directive 2001/83 describes the community code for medicinal products for human use including radiopharmaceuticals. In its current definition, also radionuclide precursors, such as fluorine-18, need to ...

    Authors: Oliver Neels, Marianne Patt and Clemens Decristoforo
    Citation: EJNMMI Radiopharmacy and Chemistry 2019 4:22
    Content type: Position paper Published on:

  8. New regulatory guidance documents from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recently been finalized or are in draft format outlining new pathways fo...

    Authors: Sally W. Schwarz and Clemens Decristoforo
    Citation: EJNMMI Radiopharmacy and Chemistry 2019 4:10
    Content type: Debate Published on:

  10. The EU regulation 536/2014 aims to facilitate the experimental use of diagnostic radiopharmaceuticals in particular for GMP requirements and needs to be applied in EU countries. As definitely clarified by this...

    Authors: G. Bormans, A. Buck, A. Chiti, M. Cooper, J. Croasdale, M. Desruet, V. Kumar, Y. Liu, I. Penuelas, C. Rossetti, R. Schiavo, S. W. Schwarz and A. D. Windhorst
    Citation: EJNMMI Radiopharmacy and Chemistry 2017 2:12
    Content type: Position paper Published on:

  11. Validation and qualification activities are nowadays an integral part of the day by day routine work in a radiopharmacy. This document is meant as an Appendix of Part B of the EANM “Guidelines on Good Radiopha...

    Authors: S. Todde, P. Kolenc Peitl, P. Elsinga, J. Koziorowski, V. Ferrari, E. M. Ocak, O. Hjelstuen, M. Patt, T. L. Mindt and M. Behe
    Citation: EJNMMI Radiopharmacy and Chemistry 2017 2:8
    Content type: Guideline article Published on:

  13. This is a position paper of the Radiopharmacy Committee of the EANM (European Association of Nuclear Medicine) addressing toxicology studies for application of new diagnostic and therapeutic radiopharmaceutica...

    Authors: J. Koziorowski, M. Behe, C. Decristoforo, J. Ballinger, P. Elsinga, V. Ferrari, P. Kolenc Peitl, S. Todde and T. L. Mindt
    Citation: EJNMMI Radiopharmacy and Chemistry 2016 1:1
    Content type: Position paper Published on:

    The Correction to this article has been published in EJNMMI Radiopharmacy and Chemistry 2018 3:13