Al-Ibraheem A, Scott AM, Abdlkadir AS, Vrachimis A, Lamoureux F, Trujillo PB, et al. Consensus Nomenclature for Radionuclide Therapy: Initial Recommendations from Nuclear Medicine Global Initiative. J Nucl Med Off Publ Soc Nucl Med J Nucl Med. 2025;66:757–63.
Pomykala KL, Hadaschik BA, Sartor O, Gillessen S, Sweeney CJ, Maughan T, et al. Next generation radiotheranostics promoting precision medicine. Ann Oncol Elsevier. 2023;34:507–19.
Jadvar H, Chen X, Cai W, Mahmood U. Radiotheranostics in Cancer Diagnosis and Management. Radiological Soc North Am. 2018;286:388–400. https://doi.org/101148/radiol2017170346.
Baum RP, Kulkarni HR. THERANOSTICS: From Molecular Imaging Using Ga-68 Labeled Tracers and PET/CT to Personalized Radionuclide Therapy - The Bad Berka Experience. Theranostics Ivyspring Int Publisher. 2012;2:437–47.
Fahey FH, Grant FD, Thrall JH. Saul Hertz, MD, and the birth of radionuclide therapy. EJNMMI Phys Springer Int Publishing. 2017;4:1–7.
SEIDLIN SM, MARINELLI LD, OSHRY E. RADIOACTIVE IODINE THERAPY. Effect on Functioning Metastases of Adenocarcinoma of the Thyroid. J Am Med Assoc Am Med Association. 1946;132:838–47.
Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, et al. Phase 3 Trial of 177 Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med New Engl J Med (NEJM/MMS). 2017;376:125–35.
Hofman MS, Violet J, Hicks RJ, Ferdinandus J, Ping Thang S, Akhurst T, et al. [ 177 Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study. Lancet Oncol Lancet Publishing Group. 2018;19:825–33.
Lange R, Ter Heine R, Decristoforo C, Peñuelas I, Elsinga PH, Van Der Westerlaken MML, et al. Untangling the web of European regulations for the preparation of unlicensed radiopharmaceuticals: A concise overview and practical guidance for a risk-based approach. Nucl Med Commun Lippincott Williams Wilkins. 2015;36:414–22.
Radiotheranostics Market Size, Share &, Growth R. 2030. [Internet]. [cited 2025 Dec 1]. https://www.grandviewresearch.com/industry-analysis/radiotheranostics-market-report. Accessed 1 Dec 2025.
Part Index | NRC.gov. https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/index.html
Gillings N, Hjelstuen O, Ballinger J, Behe M, Decristoforo C, Elsinga P, et al. Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. EJNMMI Radiopharm Chem Springer Sci Bus Media Deutschland GmbH. 2021;6:1–22. edicines (ARGPM) | Therapeutic Goods Administration (TGA). https://www.tga.gov.au/resources/resource/reference-material/australian-regulatory-guidelines-prescription-medicines-argpm.
Bakker RC, de Roos R, Ververs FFT, Lam MGEH, van der Lee MK, Zonnenberg BA, et al. Blood and urine analyses after radioembolization of liver malignancies with [166Ho]Ho-acetylacetonate-poly(l-lactic acid) microspheres. Nucl Med Biol Elsevier. 2019;71:11–8.
View of Radiotheranostics in Oncology. https://www.ijtos.com/index.php/journal/article/view/34/33
Proceedings National Regulatory. Authorities with Competence in the Safety of Radiation Sources and the Security of Radioactive Materials International Atomic Energy Agency.
Overview of Device Regulation | FDA. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
Hattangadi JA, O’Reilly JT, Recht A. US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety? J Oncol Pract. 2011;8:53.
Article PubMed PubMed Central Google Scholar
Perera M, Morris MJ. From Concept to Regulatory Drug Approval: Lessons for Theranostics. J Nucl Med. 2022;63:1793–801.
Article CAS PubMed PubMed Central Google Scholar
Radiopharmaceuticals regulatory considerations – EANM. https://eanm.org/eu-global-affairs/policy/radiopharmaceuticals-regulatory-considerations/
Clinical trials - European Commission. https://health.ec.europa.eu/medicinal-products/clinical-trials_en
Regulations and Approval/Certification of Medical Devices | Pharmaceuticals. and Medical Devices Agency. https://www.pmda.go.jp/english/review-services/reviews/0004.html
Zhang W, Zhang L, Zhao Y, Chen Y. Avid 68Ga-PSMA uptake in accessory submandibular salivary gland. Clin Nucl Med. Lippincott Williams and Wilkins; 2019;44:591–3.
Medical devices | Australian Government Department of Health and, Care A. https://www.health.gov.au/topics/medical-devices
Francis RJ, Bailey DL, Hofman MS, Scott AM. The Australasian Radiopharmaceutical Trials Network: Clinical Trials, Evidence, and Opportunity. J Nucl Med Soc Nuclear Med Inc. 2021;62:755–755.
Regulatory. Requirements and Guidelines for new Nuclear Medicine Facility. www.aerb.gov.in.
Consenting process in radiation facilities | AERB - Atomic. Energy Regulatory Board. https://aerb.gov.in/english/consenting-process-in-radiation-facilities
clinical Trials. https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/clinical-trials/
Japanese Medical Device Regulatory Approval Process. | Emergo by UL. https://www.emergobyul.com/resources/japanese-regulatory-approval-process-medical-devices
Pacific JAPANA, Baker McKenzie J, Kengo Nishigaki J, Tateishi R. Clinical Trials Handbook.
Introducing. Innovative MDs.
HSA | Medical devices. https://www.hsa.gov.sg/medical-devices
HSA Revised Guidance on Medical Device Product Registration. Specific Aspects | HSA. https://www.regdesk.co/hsa-revised-guidance-on-medical-device-product-registration-specific-aspects/
Pacific Singaporea. clinical trials handbook.
Chen A, Zhang J. Medical Device Regulations in China Meeting NMPA requirements. 2024.
A Bird’s Eye View of the Nuclear Medicine. and Radiopharmaceuticals Market in China. https://veranex.com/2024/01/12/a-birds-eye-view-of-the-nuclear-medicine/
China Introduces Revised Medical Devices Supervision and Administration. Regulations | ChemLinked. https://baipharm.chemlinked.com/news/china-introduces-revised-medical-devices-supervision-and-administration-regulations
Multijurisdictional RA. Testing Requirements. 2021.
Commission I of M (US). C for R and E of the MUP of the NR. In: Gottfried K-LD, Penn G, editors. Regulation and Radiation Medicine. National Academies Press (US); 1996. https://www.ncbi.nlm.nih.gov/books/NBK232722/.
Bodei L, Herrmann K, Schöder H, Scott AM, Lewis JS. Radiotheranostics in oncology: current challenges and emerging opportunities. Nat Rev Clin Oncol. 2022;19:534.
Article CAS PubMed PubMed Central Google Scholar
Review 9 M Re-examination Period: (Exclusivity Period) 8-10years. 2021; www.iqvia.co.jp
Home | ARPANSA [Internet]. [cited 2024 Dec 2]. https://www.arpansa.gov.au/. Accessed 2 Dec 2024.
Fillimi [Internet]. [cited 2025 Dec 5]. https://akbpm.gov.al/. Accessed 5 Dec 2025.
Bundesamt für Sicherheit im Gesundheitswesen [Internet]. BASG. [cited 2025 Dec 5]. https://www.basg.gv.at/. Accessed 5 Dec 2025.
Medical devices | European Medicines Agency (EMA). https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices
National Health Regulatory Authority Bahrain [Internet]. [cited 2025 Dec 5]. https://www.nhra.bh/. Accessed 5 Dec 2025.
Bangladesh Atomic Energy Commission-Government of the People’. s Republic of Bangladesh [Internet]. [cited 2025 Dec 5]. https://baec.gov.bd/. Accessed 5 Dec 2025.
Department of Drug Administration-Government of the People’. s Republic of Bangladesh [Internet]. [cited 2025 Dec 5]. https://dgda.gov.bd/. Accessed 5 Dec 2025.
FANC - Federal Agency for Nuclear Control. | Protecting Together [Internet]. [cited 2025 Dec 5]. https://fanc.fgov.be/nl. Accessed 5 Dec 2025.
FAMHP | Your medicine. and health products [Internet]. [cited 2025 Dec 5]. https://www.famhp.be/en. Accessed 5 Dec 2025.
Agency for Medicines Product and Medical. Devices of Bosnia and Herzegovina [Internet]. [cited 2025 Dec 5]. https://almbih.gov.ba/en/agencija-za-lijekove-i-medicinska-sredstva-bosne-i-hercegovine-eng/. Accessed 5 Dec 2025.
BDA - Official website of the Bulgarian. Medicines Agency under the Ministry of Health of the Republic of Bulgaria [Internet]. [cited 2025 Dec 5]. https://www.bda.bg/bg/. Accessed 5 Dec 2025.
Instituto de Salud. Pública de Chile [Internet]. [cited 2025 Dec 5]. https://www.ispch.cl/. Accessed 5 Dec 2025.
Comisión Chilena de. Energía Nuclear [Internet]. [cited 2025 Dec 5]. https://www.cchen.cl/. Accessed 5 Dec 2025.
Canada H. Medical devices [Internet]. 2004 [cited 2025 Dec 5]. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html. Accessed 5 Dec 2025.
HALMED. HALMED - Agencija za lijekove i medicinske proizvode [Internet]. HALMED - Agencija Za Lijek. Med. Proizv. [cited 2025 Dec 5]. https://www.halmed.hr/. Accessed 5 Dec 2025.
Úvodní stránka -. Oficiální stránky Státního ústavu pro kontrolu léčiv [Internet]. SÚKL. [cited 2025 Dec 5]. https://sukl.gov.cz/. Accessed 5 Dec 2025.
Úvod -. SÚJB [Internet]. [cited 2025 Dec 5]. https://sujb.gov.cz/. Accessed 5 Dec 2025.
Lægemiddelstyrelsen [Internet]. Lægemiddelstyrelsen. [cited 2025 Dec 5]. https://laegemiddelstyrelsen.dk/da/. Accessed 5 Dec 2025.
Homepage - ENRRA [Internet]. [cited 2025 Dec 5]. https://enrra.org/. Accessed 5 Dec 2025.
Avaleht | Ravimiamet [Internet]. [cited 2025 Dec 5]. https://ravimiamet.ee/. Accessed 5 Dec 2025.
Etusivu [Internet]. Fimea. [cited 2025 Dec 5]. https://fimea.fi/etusivu. Accessed 5 Dec 2025.
Home | Radiation and Nuclear Safety Authority STUK [Internet]. [cited 2025 Dec 5]. https://stuk.fi/etusivu. Accessed 5 Dec 2025.
Accueil [Internet]. ANSM. [cited 2025 Dec 5]. https://ansm.sante.fr/. Accessed 5 Dec 2025.
BfArM - Startseite. [Internet]. [cited 2025 Dec 5]. https://www.bfarm.de/DE/Home/_node.html. Accessed 5 Dec 2025.
Hellenic Atomic Energy Commission [Internet]. [cited 2025 Dec 5]. https://www.eeae.gr/. Accessed 5 Dec 2025.
Országos Gyógyszerészeti és. Élelmezés-egészségügyi Intézet [Internet]. Orsz. Gyógyszerészeti És Élelmez.-Egészségügyi Intéz. [cited 2025 Dec 5]. https://ogyei.gov.hu/nyitooldal. Accessed 5 Dec 2025.
Országos Atomenergia Hivatal. [Internet]. [cited 2025 Dec 5]. https://www.haea.hu/web/v3/OAHPortal.nsf/web?OpenAgent. Accessed 5 Dec 2025.
Brandoctors. Beranda | Badan Pengawas Obat dan Makanan [Internet]. [cited 2025 Dec 5]. https://www.pom.go.id. Accessed 5 Dec 2025.
Agenzia Italiana del Farmaco [Internet]. [cited 2025 Dec 5]. https://www.aifa.gov.it/. Accessed 5 Dec 2025.
KNRA – Kenya Nuclear Regulatory Authority. [Internet]. [cited 2025 Dec 5]. https://knra.co.ke/. Accessed 5 Dec 2025.
Pautan Pintas Portal Rasmi [Internet]. [cited 2025 Dec 5]. https://www.mda.gov.my/. Accessed 5 Dec 2025.
Home - Food and Drug Administration [Internet]. 2021 [cited 2025 Dec 5]. https://www.fda.gov.ph/. Accessed 5 Dec 2025.
| الموقع الإلكتروني. الرسمي للهيئة العامة للغذاء والدواء [Internet]. [cited 2025 Dec 5]. https://www.sfda.gov.sa/. Accessed 5 Dec 2025.
SAHPRA - South African. Health Products Regulatory Authority [Internet]. SAHPRA. [cited 2025 Dec 5]. https://www.sahpra.org.za/. Accessed 5 Dec 2025.
Medicines and Healthcare products Regulatory Agency [Internet]. GOV.UK. 2025 [cited 2025 Dec 5]. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency. Accessed 5 Dec 2025.
Brightwire.net. Home [Internet]. Off. Nucl. Regul. https://www.brightwire.net; 2025 [cited 2025 Dec 5]. https://www.onr.org.uk/. Accessed 5 Dec 2025.
Australian Regulatory Guidelines for Prescription Medicines (ARGPM) | Therapeutic Goods Administration (TGA). https://www.tga.gov.au/resources/resource/reference-material/australian-regulatory-guidelines-prescription-medicines-argpm
Guidance for Industry and Researchers the Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application. 2010; https://www.reginfo.gov
Regulations. Good Clinical Practice and Clinical Trials | FDA. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials
Administration D. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics Guidance for Industry. 2018;https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orhttps://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Radiation protection legislation - European Commission. https://energy.ec.europa.eu/topics/nuclear-energy/radiation-protection/radiation-protection-legislation_en
Directive – 2013/59 - EN - EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32013L0059
Medical Technology Regulations. - MedTech Europe. https://www.medtecheurope.org/new-medical-technology-regulations/
Van Norman GA, Drugs. Comparison of European and U.S. Approval Processes. JACC Basic Transl Sci Elsevier Inc. 2016;1:399–399.
www.topra.org/CPDsupplements i CPD with Regulatory Rapporteur. 2019; https://eur-lex.europa.eu/
Clinical Trials Regulation | European Medicines Agency (EMA). https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-regulation
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