Virus safety evaluation of biotechnological investigational medicinal products - Scientific guideline

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

Adopted Reference Number: EMEA/CHMP/BWP/398498/2005 Legal effective date: 01/02/2009

English (EN) (71.62 KB - PDF)

Публикувано за първи път: 24/07/2008 Последна актуализация: 24/07/2008

Overview of comments received on draft guideline on virus safety evaluation of biotechnological investigational medicinal products

Reference Number: EMEA/CHMP/BWP/67410/2007

English (EN) (320.89 KB - PDF)

Публикувано за първи път: 17/09/2008 Последна актуализация: 17/09/2008

Draft guideline on virus safety evaluation of biotechnological investigational medicinal products

Draft: consultation closed Reference Number: EMEA/CHMP/BWP/398498/2005-corr

English (EN) (101.45 KB - PDF)

Публикувано за първи път: 28/06/2006 Последна актуализация: 28/06/2006

Concept paper on the development of a guideline on viral safety evaluation of biotechnological products to be used in clinical trials

Reference Number: EMEA/CHMP/BWP/124447/2004

English (EN) (144.59 KB - PDF)

Публикувано за първи път: 15/12/2004 Последна актуализация: 15/12/2004