EMA opens consultation on revised radiopharmaceuticals quality guideline
The European Medicines Agency (EMA) has published a draft revised guideline on quality requirements for radiopharmaceuticals, opening public consultation. The guidance replaces the 2007 radiopharmaceuticals guideline and provides comprehensive requirements for Module 3 quality documentation in marketing authorisation applications. It covers four product types: ready-for-use radiopharmaceuticals, kits for radiopharmaceutical preparation, radionuclide generators and radionuclide precursors. The consultation ends on 30 April 2026.