Investigational Medicinal Product Dossier (IMPD)

An Investigational Medicinal Product Dossier (IMPD) is a detailed document that provides comprehensive information about a new medicine being tested in clinical trials. It includes details on the medicine’s composition, manufacturing process, quality control, and safety data. The purpose of the IMPD is to demonstrate that the investigational drug is suitable for human testing and complies with regulatory standards. Regulatory authorities review the IMPD to ensure the safety of participants and the integrity of the trial before approving the start of clinical research.