Update – Guideline on the Requirements to Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials

On 4 February 2022 the European Commission announced the revision 2 on the requirements for quality documentation of chemical and pharmaceutical IMPs in clinical trials.

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 radioactive/radio-labelled substances to be submitted to the competent authority for approval prior to beginning a clinical trial in humans. It includes the requirements for IMPs and Auxiliary Medicinal Products to be tested in phase I, phase II, phase III and phase IV studies as well as the requirements for modified and unmodified comparator products and IMPs to be tested in generic bioequivalence studies.

When compiling the quality part of the IMPD for phase II and phase III clinical studies, the larger and longer exposure of patients to the product have to be taken into account compared to phase I clinical studies. Based on the diversity of products to be used in the different phases of clinical trials, the requirements defined in this guideline can only be of an illustrative nature and cannot be expected to present an exhaustive list. IMPs based on innovative and/or complex technologies may need more detailed data to be submitted. For certain situations, e.g. where the drug substance from the specific source to be used for an IMP is already included in a medicinal product authorized within the EU, not all the documentation outlined in the following chapters need to be submitted in the IMPD, but a simplified IMPD will suffice.

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