FDA, EMA and NMPA differ in how they assess radiopharmaceuticals, review finds

Radiopharmaceuticals occupy an unusual position in drug regulation, because every product combines a targeting molecule with a radioactive component, and regulators must judge both at once. A review published in EJNMMI Radiopharmacy and Chemistry examines how three major regulatory authorities, the U.S. Food and Drug Administration, the European Medicines Agency and the China National Medical Products Administration, approach this dual challenge, and how the International Atomic Energy Agency supports efforts to align their requirements.

According to the review, all three frameworks share a common scientific foundation. Each applies a dual-component risk paradigm that simultaneously evaluates the molecular targeting characteristics of the product and its radiobiological effects. Each also relies on the same core categories of non-clinical studies, covering pharmacology, biodistribution, toxicology and dosimetry, and each accepts the principles of good laboratory practice, alongside agreed flexibilities in how those principles are applied.

Where the frameworks diverge is in philosophy and method. The review characterizes the FDA’s approach as radiation-proportionate and precautionary, the EMA’s strategy as risk-proportionate, and the NMPA’s model as a hybrid integrative approach. The author identifies key differences among the three authorities in species selection for non-clinical studies, in the scope of toxicology programs, and in the role that dosimetry plays in the overall assessment.

The review also discusses the IAEA as a distinct kind of harmonization body. Unlike the three regulatory authorities, the IAEA does not act as a regulator. Instead, it provides harmonized technical guidance, technical standards, capacity-building tools and practical protocols that support regulators and developers working across jurisdictions.

Several emerging trends are highlighted in the analysis.

The review’s conclusion points toward possible pathways for global alignment. The author argues that clarifying shared principles and strategic divergences across jurisdictions offers a practical roadmap for global radiopharmaceutical development, and identifies three needs: tiered, risk-proportionate quality frameworks; validation of alternative models to replace or reduce animal studies; and incorporation of personalized dosimetry into future regulatory guidance.

The analysis also raises the prospect of a future harmonized ICH framework specifically tailored for radiopharmaceuticals.

It is important to note the scope of this work. The article is a review, published on 30 September 2026, that compares and analyzes existing regulatory frameworks and guidance; it does not report new experimental findings, and its conclusions about harmonization pathways are the author’s analysis rather than results of a clinical or laboratory study. The article is open access and is currently available as an accepted manuscript version, subject to further editorial processing before the final version of record.

For developers and regulators, the practical takeaway from the review is that the three major frameworks rest on shared scientific ground even when their procedural philosophies differ, and that understanding those differences, in species selection, toxicology scope and dosimetry, may help sponsors design non-clinical packages that satisfy multiple jurisdictions at once. The review suggests that progress toward alignment will depend on validating alternative non-clinical models, adapting quality frameworks to the risk profile of each product, and building personalized dosimetry into future guidance.

Subject of Research: Regulatory frameworks for non-clinical evaluation of radiopharmaceuticals

Article Title: Global strategies for non-clinical evaluation of radiopharmaceuticals: comparing regulatory pathways and international harmonization efforts

Article References: Chen, H., Li, S., & Wang, L. (2026). Global strategies for non-clinical evaluation of radiopharmaceuticals: comparing regulatory pathways and international harmonization efforts. EJNMMI Radiopharmacy and Chemistry. https://doi.org/10.1186/s41181-026-00501-8

Image Credits: AI Generated

DOI: 10.1186/s41181-026-00501-8

Keywords: radiopharmaceuticals, FDA, EMA, NMPA, IAEA, non-clinical evaluation, regulatory harmonization, dosimetry, toxicology, GLP, 3Rs, ICH