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
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Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 2 (PDF/428.19 KB)
Adopted
First published: 28/01/2022
Legal effective date: 31/01/2022
EMA/CHMP/BWP/534898/2008 Rev. 2 -
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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) (PDF/558.78 KB)
First published: 28/01/2022
EMA/CHMP/BWP/518880/2021 -
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Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 2 (PDF/401.55 KB)
Draft: consultation closed
First published: 01/07/2021
Consultation dates: 01/07/2021 to 31/08/2021
EMA/CHMP/BWP/534898/2008 Rev. 2
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Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 1 (PDF/210.49 KB)
Adopted
First published: 26/10/2017
Last updated: 07/11/2018
Legal effective date: 26/04/2018
EMA/CHMP/BWP/534898/2008 Rev. 1 corrigendum -
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Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials with tracked changes - Revision 1 (PDF/210.85 KB)
Adopted
First published: 07/11/2018
EMA/CHMP/BWP/534898/2008 rev. 1 corrigendum -
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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 (PDF/535.03 KB)
First published: 26/10/2017
Last updated: 26/10/2017
EMA/CHMP/BWP/563769/2017 -
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Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 1 (PDF/216.7 KB)
Draft: consultation closed
First published: 01/07/2016
Last updated: 01/07/2016
Consultation dates: 01/07/2016 to 31/12/2016
EMA/CHMP/BWP/534898/2008 Rev. 1 -
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Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials: document with track changes - Revision 1 (PDF/335.26 KB)
First published: 21/07/2016
Last updated: 21/07/2016
EMA/CHMP/BWP/534898/2008 Rev. 1
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Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - First version (PDF/178.27 KB)
Adopted
First published: 14/05/2012
Last updated: 14/05/2012
Legal effective date: 15/04/2012
EMA/CHMP/BWP/534898/2008 -
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Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - First version (PDF/204.14 KB)
Draft: consultation closed
First published: 11/03/2010
Last updated: 11/03/2010
Consultation dates: 18/02/2010 to 31/08/2010
EMA/CHMP/BWP/534898/2008 -
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Concept paper on a guideline on the chemical and pharmaceutical quality documentation concerning biological investigational medicinal products in clinical trials (PDF/51.88 KB)
First published: 21/02/2008
Last updated: 21/02/2008
EMEA/CHMP/BWP/466097/2007