ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Investigational Medicinal Product Dossier (IMPD)

The IMPD provides a summary of information on quality of the investigational medicinal product to be used in the clinical trial, including reference products and placebos. It also provides data from non-clinical studies and available previous clinical experience with the use of the investigational medicinal product. An overall risk-benefit assessment, critically analyzing the non-clinical and clinical data in relation to the potential risks and benefits of the proposed trial must also be included. A simplified IMPD may be submitted if information related to the investigational medicinal product has been assessed previously as part of a marketing authorization.

Following implementation of the European Clinical Trials Directive (2001/20/EC) into national law of the European Member States, an IMPD is now required to accompany an application to perform clinical trials in any European Member State.

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