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
English (EN) (428.19 KB - PDF)
Document history - Revision 2
Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 2
English (EN) (428.19 KB - PDF)
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)
English (EN) (558.78 KB - PDF)
Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 2
English (EN) (401.55 KB - PDF)
Document history - Revision 1
Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 1
English (EN) (210.49 KB - PDF)
Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials with tracked changes - Revision 1
English (EN) (210.85 KB - PDF)
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
English (EN) (535.03 KB - PDF)
Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 1
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.
English (EN) (216.7 KB - PDF)
Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials: document with track changes - Revision 1
Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials: document with track changes
English (EN) (335.26 KB - PDF)
Document history - First version
Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - First version
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.
English (EN) (178.27 KB - PDF)
Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - First version
English (EN) (204.14 KB - PDF)
Concept paper on a guideline on the chemical and pharmaceutical quality documentation concerning biological investigational medicinal products in clinical trials
English (EN) (51.88 KB - PDF)
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