Guideline on Requirements for Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products (IMPs) in Clinical Trials

On 28 January 2022 the EMA published guidance to define harmonized requirements for documentation submitted throughout the EU.

This guidance addresses the documentation on the chemical and pharmaceutical quality of IMP dossiers 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.

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