ANVISA Normative Instruction No. 433, of April 1, 2026: Approves the Lists of Radiopharmaceuticals for Therapeutic and Diagnostic Use That May Present Literature Data to Demonstrate Safety and Efficacy

The document outlines the official lists of radiopharmaceutical substances permitted for registration, notification, import, and quality control based on clinical evidence. It covers legal basis for ANVISA's approval, applicable regulations, lists of radiopharmaceuticals for diagnostic (Annex I) and therapeutic use (Annex II), requirements for literature data to prove efficacy and safety, and identification by common name and CAS number. Revokes previous normative instructions and enters into force on 06-Apr-2026.