The National Health Surveillance Agency (ANVISA) has launched a public consultation aimed at updating the list of radiopharmaceuticals for established use, in accordance with Regulatory Instruction (NI) 81/2020.

This consultation, available for a period of 30 days and open until September 12, 2025, seeks to gather input to allow the inclusion of new drugs on the list.

Radiopharmaceuticals considered for established use are those whose safety and efficacy have been demonstrated through documented scientific evidence, which exempts them from the need for specific clinical studies. These products have a history of extensive clinical use and technical and scientific recognition.

WHOM DOES IT IMPACT?

The direct impact is on healthcare professionals, medical and diagnostic institutions, patients, and the pharmaceutical and radiopharmaceutical industries.

CONCLUSION:

This measure represents a significant advance in maintaining clinical practice aligned with the latest scientific evidence, optimizing the safety and efficacy of radiopharmaceuticals, and promoting both innovation in the sector and patient access to quality treatments.