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

Current effective version

Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 2

AdoptedLegal effective date: Reference Number: EMA/CHMP/QWP/545525/2017 Rev. 2

English (EN) (239.66 KB - PDF)

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Revision 2

Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 2

AdoptedLegal effective date: Reference Number: EMA/CHMP/QWP/545525/2017 Rev. 2

English (EN) (239.66 KB - PDF)

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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'

Reference Number: EMA/CHMP/QWP/693578/2021

English (EN) (6.59 MB - PDF)

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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

Consultation dates: to Draft: consultation closedReference Number: EMA/CHMP/QWP/545525/2017 Rev. 2 *Corr.

English (EN) (563.49 KB - PDF)

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Revision 1

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

AdoptedLegal effective date: Reference Number: EMA/CHMP/QWP/545525/2017

English (EN) (358.15 KB - PDF)

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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'

Reference Number: EMA/CHMP/QWP/546045/2017

English (EN) (486.67 KB - PDF)

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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

Consultation dates: to Draft: consultation closedReference Number: EMA/CHMP/QWP/834816/2015Summary:

This guideline addresses the documentation on the chemical and pharmaceutical quality of IMPs and Auxiliary Medicinal Products containing chemically defined drug substances, synthetic peptides, synthetic oligonucleotides, 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.

English (EN) (355.16 KB - PDF)

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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

Consultation dates: to Draft: consultation closedReference Number: EMA/CHMP/QWP/126334/2015Summary:

This concept paper addresses the need to update and revise the CHMP/QWP/185401/2004 final guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials. This guideline was originally adopted on 23rd March 2006 and came into operation on 1st October 2006.

English (EN) (74.74 KB - PDF)

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First version

Guideline on the requirements to the chemical and pharmaceuticalquality documentation concerning investigational medicinal products in clinical trials - First version

AdoptedLegal effective date: Reference Number: CHMP/QWP/185401/2004

English (EN) (140.69 KB - PDF)

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