Investigational Medicinal Product Dossier IMPD Definition & Meaning | Health Care Term | CSIMarket
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Investigational Medicinal Product Dossier IMPD

Health Care Term

An Investigational Medicinal Product Dossier (IMPD) is a comprehensive document that provides detailed information about a medicinal product that is being developed. It is an important tool in the process of obtaining clinical trial authorisation for an investigational medicinal product (IMP). The IMPD is submitted as part of the regulatory application to the European Medicines Agency (EMA) or national competent authorities.

The IMPD contains information on the quality, safety, and efficacy of the medicinal product. It includes data on the manufacturing process, specifications of the active substance and the finished product, and stability data. It also contains information on non-clinical and clinical studies carried out with the product, as well as the proposed clinical trial protocol.

The IMPD is used by regulatory authorities to evaluate the safety and efficacy of the product. It ensures that the product is developed and manufactured in a way that is consistent with good manufacturing practices and that the clinical trials are designed in a way that will generate reliable data. It is also used by clinical investigators to inform them about the product and to help them design the clinical trial.

In summary, the IMPD is an essential tool in the development of a new medicinal product. It provides a comprehensive overview of the product, including its quality, safety, and efficacy, and plays a crucial role in the regulatory approval process.


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