Harmonization of U.S., European Union, and Canadian First-in-human regulatory requirements for radiopharmaceuticals: Is this possible?

Abstract

In recent years, several new radiotracers and radionuclide therapies have been developed. There is a renaissance in nuclear medicine and molecular imaging today in terms of, for example, the ability to image and treat neuroendocrine and prostate malignancies. To be able to bring a new drug product from bench to bedside and assist patients while also ensuring patient safety, stringent regulations must be met. However, differences in regulatory requirements, often based on jurisdictional politics rather than scientific evidence, can hinder global cooperation, increase expense, and slow progress. In an effort to rise above these differences, nuclear medicine professional organizations, regulators, and international agencies have begun to identify commonalities in the regulations to achieve harmonization. Indeed, a more streamlined approach to radiopharmaceutical drug development across jurisdictions could be achieved through establishing harmonized requirements for preclinical studies and manufacturing standards. This paper provides an educational overview of the regulatory and submission requirements governing investigational radiopharmaceuticals for first-in-human radiopharmaceuticals across the European and North American continents. It is hoped that through ongoing collaboration, regulatory reform and harmonization can become a reality and speed access to the most up-to-date evidence-based patient care for all.