EMA Seeks Comments on Planned Nonclinical Guidance for Radiopharmaceuticals

The European Medicines Agency invited stakeholders to comment on a planned guidance on nonclinical development of radiopharmaceutical products.

The agency issued the invitation hoping to speed the development process. For example, if a radiopharmaceutical’s unlabeled ingredients, or “cold parts,” are common or their dosage is low enough to have minimal effect, the agency proposes allowing reduced nonclinical development.

The planned guidance will also address the outcomes of biodistribution studies for cold parts, types of clinical setting such as first-in-human clinical trials and dosing frequency, and good laboratory practice requirements.