Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the investigational medicinal product(s) (IMP) provided by the trial sponsor.
Investigational Medicinal Product Dossier
The Investigational Medicinal Product Dossier is a document divided in four distinct sections. It provides information on (i) the quality, manufacture and control of the IMP, (ii) the non-clinical studies conducted with the IMP, (iii) the clinical use of the IMP, and (iv) the overall risk / benefit assessment of the IMP in the proposed trial.
IMPD in the European Union
An IMPD is one of the essential documents that form the CTA submitted to the EU Competent Authorities (CAs) for non-authorized IMPs. Where the IMP is subject of a marketing authorization, the Summary of Product Characteristics, complemented by additional data as necessary, could be submitted in lieu of the IMPD.
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