Investigational Medicinal Product Dossier (IMPD)

The IMP dossier (IMPD) gives information related to the quality of any IMP (i.e. including reference product and placebo), manufacture and control of the IMP, and data from non-clinical studies and from its clinical use. It is requred as part of a Clinical Trial Application in the EU for certain trials.

Source: EUROPEAN COMMISSION Communication from the Commission — Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1) (2010/C 82/01)


Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.