This document provides scientific guidance on the viral safety of biotechnological medicinal products used in clinical trials.
Keywords: Virus safety, clinical trial, investigational medicinal products (IMPs)
Current effective version
Guideline on virus safety evaluation of biotechnological investigational medicinal products
English (EN) (71.62 KB - PDF)
Document history
Overview of comments received on draft guideline on virus safety evaluation of biotechnological investigational medicinal products
English (EN) (320.89 KB - PDF)
Draft guideline on virus safety evaluation of biotechnological investigational medicinal products
English (EN) (101.45 KB - PDF)
Concept paper on the development of a guideline on viral safety evaluation of biotechnological products to be used in clinical trials
English (EN) (144.59 KB - PDF)
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