Radiopharmaceuticals - Scientific guideline

This document describes the specific additional information that needs to be submitted in relation to radiopharmaceuticals, in the context of applications for marketing authorisations or variations to authorised medicinal products.

Keywords: Radiopharmaceuticals, pharmaceutical and chemical documentation, development, manufacture, quality control, stability

Current effective version - Currently under revision see below

Guideline on radiopharmaceuticals - Revision 1

Adopted Reference Number: EMEA/CHMP/QWP/306970/2007 Legal effective date: 01/05/2009

Open consultation

Draft guideline on quality of radiopharmaceuticals - Revision 2

Draft: consultation open Consultation dates: 10/12/2025 to 30/04/2026 Reference Number: EMA/CHMP/QWP/363827/2025 Summary:

This guideline replaces the ‘Guideline on Radiopharmaceuticals’ (EMEA/CHMP/QWP/306970/2007). Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Concept paper on the revision of the 'Guideline on Radiopharmaceuticals - Revision 1'

Draft: consultation closed Consultation dates: 21/07/2023 to 31/10/2023 Reference Number: EMA/CHMP/QWP/298182/2023

Document history - Revision 1

Guideline on radiopharmaceuticals - Revision 1

Adopted Reference Number: EMEA/CHMP/QWP/306970/2007 Legal effective date: 01/05/2009

Overview of comments received on draft guideline on radiopharmaceuticals

Reference Number: EMEA/CHMP/CVMP/QWP/567962/2008

Draft guideline on radiopharmaceuticals

Draft: consultation closed Reference Number: EMEA/CHMP/QWP/306970/2007

Concept paper on the revision of the note for guidance on radiopharmaceuticals

Reference Number: EMEA/CHMP/92877/2005

Document history - First version

Radiopharmaceuticals

Adopted Reference Number: 3AQ20A Legal effective date: 01/06/1991