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Preparation of an ATMP-specific product dossier

The ATMP facility supports researchers in writing the IMPD for their ATMP.

The Investigational Medicinal Product Dossier (IMPD) is the basis for approval of clinical trials by the competent authorities. The IMPD includes summaries of information related to the quality, manufacture and control of the Investigational Medicinal Product. An overall risk-benefit assessment, critical analyses of the non-clinical and clinical data in relation to the potential risks and benefits of the proposed study have to be part of the IMPD.

Over the years, the ATMP facility has acquired knowledge and experience on writing an IMPD for ATMP which are intrinsically complex products derived from a variety of biological materials, such as cells, tissues or viral vectors.

The ATMP facility supports researchers in writing the IMPD for their ATMP.

A manual to develop and write an IMPD for an ATMP and an example of a CCMO-approved IMPD for an ATMP are available.