Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Scientific guideline
Table of contents
This guidance addresses the documentation on the chemical and pharmaceutical quality of investigational medicinal product dossier containing chemically defined drug substances, synthetic peptides, herbal substances, herbal preparations and chemically defined radio-active/radio-labelled substances to be submitted to the competent authority for approval prior to beginning a clinical trial in humans.
Please note that requirements related to the Clinical Trial Regulation will apply only on entry into application of the Regulation. Scientific requirements apply from 28 May 2018.
Keywords: Clinical trial, quality
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Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 2 (PDF/239.66 KB)
Adopted
First published: 28/01/2022
Legal effective date: 31/01/2022
EMA/CHMP/QWP/545525/2017 Rev. 2 -
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Overview of comments received on 'Draft guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 2' (PDF/6.59 MB)
First published: 28/01/2022
EMA/CHMP/QWP/693578/2021 -
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Draft guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 2 (PDF/563.49 KB)
Draft: consultation closed
First published: 01/07/2021
Consultation dates: 01/07/2021 to 31/08/2021
EMA/CHMP/QWP/545525/2017 Rev. 2 *Corr.
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Guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 1 (PDF/358.15 KB)
Adopted
First published: 28/11/2017
Last updated: 28/11/2017
Legal effective date: 14/03/2018
EMA/CHMP/QWP/545525/2017 -
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Overview of comments received on 'Guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 1' (PDF/486.67 KB)
First published: 28/11/2017
Last updated: 28/11/2017
EMA/CHMP/QWP/546045/2017 -
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Draft guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 1 (PDF/355.16 KB)
Draft: consultation closed
First published: 12/04/2016
Last updated: 12/04/2016
Consultation dates: 12/04/2016 to 12/10/2016
EMA/CHMP/QWP/834816/2015 -
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Draft concept paper on the need for revision of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 1 (PDF/74.74 KB)
Draft: consultation closed
First published: 30/03/2015
Last updated: 30/03/2015
Consultation dates: 30/03/2015 to 30/06/2015
EMA/CHMP/QWP/126334/2015