An Investigational Medicinal Product Dossier (IMPD) is the regulatory dossier used in many regions (especially the EU/UK) to describe the quality, manufacture, control testing, and safety information for an IMP.
It includes Chemistry, Manufacturing, and Controls (CMC) details and relevant nonclinical/clinical information needed to justify use in humans. For multinational trials, the IMPD supports clinical trial authorization processes and helps regulators evaluate product quality and risk. Sponsors maintain IMPDs to document changes, ensure traceability, and support consistent product supply across sites. A strong IMPD reduces avoidable delays by providing complete, review-ready evidence on IMP quality and safety.