Requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Scientific guideline

This guidance addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of investigational medicinal product (IMP) containing biological/biotechnology derived substances. It applies to cases where no 'simplified IMP Dossier' is submitted.

Please note that requirements related to the Clinical Trial Regulation will apply only on entry into application of the Regulation. Scientific requirements apply from 26 April 2018.

Keywords: Biological product, investigational medicinal product (IMP), clinical trial, quality

Current effective version

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 2

Adopted Reference Number: EMA/CHMP/BWP/534898/2008 Rev. 2 Legal effective date: 31/01/2022

Document history - Revision 2

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 2

Adopted Reference Number: EMA/CHMP/BWP/534898/2008 Rev. 2 Legal effective date: 31/01/2022

Overview of comments received on the draft Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials (EMA/CHMP/BWP/534898/2008 Rev. 2)

Reference Number: EMA/CHMP/BWP/518880/2021

Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 2

Draft: consultation closed Consultation dates: 01/07/2021 to 31/08/2021 Reference Number: EMA/CHMP/BWP/534898/2008 Rev. 2

Document history - Revision 1

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 1

Adopted Reference Number: EMA/CHMP/BWP/534898/2008 Rev. 1 corrigendum Legal effective date: 26/04/2018

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials with tracked changes - Revision 1

Adopted Reference Number: EMA/CHMP/BWP/534898/2008 rev. 1 corrigendum

Overview of comments received on ‘Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials’ (EMA/CHMP/BWP/534898/2008 Rev. 1) - Revision 1

Reference Number: EMA/CHMP/BWP/563769/2017

Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 1

Draft: consultation closed Consultation dates: 01/07/2016 to 31/12/2016 Reference Number: EMA/CHMP/BWP/534898/2008 Rev. 1 Summary:

The following guideline is to be seen in connection with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, which came into force on June 20, 2014.

Since clinical trials can be designed as multi-centre studies potentially involving different member states, it is the aim of this guideline to define harmonised requirements for the documentation to be submitted throughout the European Union.

Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials: document with tracked changes - Revision 1

Reference Number: EMA/CHMP/BWP/534898/2008 Rev. 1 Summary:

Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials: document with track changes

Document history - First version

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - First version

Adopted Reference Number: EMA/CHMP/BWP/534898/2008 Legal effective date: 15/04/2012 Summary:

This guideline addresses the specific documentation requirements on the biological, chemical and

pharmaceutical quality of IMP containing biological / biotechnology derived substances in cases where

no 'simplified IMPD' is submitted.

Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - First version

Draft: consultation closed Consultation dates: 18/02/2010 to 31/08/2010 Reference Number: EMA/CHMP/BWP/534898/2008

Concept paper on a guideline on the chemical and pharmaceutical quality documentation concerning biological investigational medicinal products in clinical trials

Reference Number: EMEA/CHMP/BWP/466097/2007