The Movement to Harmonize Radiopharmaceutical Regulatory Requirements

Feb 5, 2019 | Radiopharmaceuticals, Regulatory Agency


A team of distinguished researchers recently published a call for the global harmonization of regulatory requirements for radiopharmaceuticals. They note that we are currently experiencing a renaissance in nuclear medicine and molecular imaging in the present period. Innovative new radiopharmaceutical technologies enter the market annually—from new radiotracers to radionuclide therapies.

Much as the global biopharmaceutical industry has established standards such as ICH, the industry will need to harmonize stringent regulatory requirements across regions. The authors note that today radiopharmaceutical regulatory differences exhibit “jurisdictional politics rather than scientific evidence.” Results can hinder global collaboration, increase costs and deaccelerate timelines.  

The authors note that nuclear medicine professionals, interest groups, regulators, companies and international agencies are identifying commonalities in pursuit of harmonization.  For an educational overview of the movement toward a global radiopharmaceutical regulatory harmonization framework follow the link below for the entire read.


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