Developing Marketing Authorisation Dossier of a Radiopharmaceutical: The EAEU Procedure

INTRODUCTION. Radiopharmaceuticals (radiopharmaceutical medicinal products) are used in clinical practice to diagnose and treat a wide range of diseases. However, regulatory acts of the Eurasian Economic Union give no detailed requirements for a section dedicated to clinical documentation in the authorisation dossier currently developed as Common Technical Document (CTD) used to assess safety and effectiveness of this drug category.

AIM. This study aimed to identify transparent principles used to draft clinical modules of authorisation dossiers for various types of radiopharmaceuticals based on analysed provisions of the current EAEU legislation, recommendations by international regulatory authorities, and the expertise.

DISCUSSION. Drug authorisation in the EAEU and adjusting national authorisation dossiers with the broader EAEU requirements (including new countries of recognition) requires a full dataset on clinical studies of radiopharmaceuticals. Radiopharmaceuticals have a whole range of specific traits, both due to the nature of these products and their clinical use. Specific traits of radiopharmaceuticals shall be thoroughly studies and described in the dossier documents. This study analysed the current EAEU regulatory documents and recommendations given by: Swiss Agency for Therapeutic Products (Swissmedic) and Canada Ministry of Health (Health Canada). The authors developed possible scenarios of submitting full dossiers required for a radiopharmaceutical, according to their type / kind and clinical use.

CONCLUSIONS. The methods described to develop dossiers for various types / kinds of radiopharmaceuticals will help drug developers and regulatory affairs managers fully comply with the authorisation procedures.

1. Goryachev DV, Lysikova IV, Chernaia AA, Kushnir DD. Planning a clinical development programme for radiopharmaceuticals: an analysis of international guidelines and expertise. Regulatory Research and Medicine Evaluation. 2025;15(1):105–20 (In Russ.). https://doi.org/10.30895/1991-2919-2025-15-1-105-120

2. Rychikhina EM, Tkachenko OG, Kosenko VV. Recommendations on the EAEU marketing authorisation procedures to optimise the performance of regulatory affairs specialists. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation. 2023;13(2–1):345–60 (In Russ.). https://doi.org/10.30895/1991-2919-2023-544

3. Bolch WE, Eckerman KF, Sgouros G, Thomas SR. MIRD pamphlet No. 21: a generalized schema for radiopharmaceutical dosimetry — standardization of nomenclature. J Nucl Med. 2009;50(3):477–84. https://doi.org/10.2967/jnumed.108.056036

4. Menzel HG, Clement C, DeLuca P. ICRP Publication 110. Realistic reference phantoms: an ICRP/ICRU joint effort. A report of adult reference computational phantoms. Ann ICRP. 2009;39(2):1–164. https://doi.org/10.1016/j.icrp.2009.09.001