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The IND requires very detailed product and development data such as information related to manufacturing, data from nonclinical studies, and previous clinical studies related to the IMP. IND also requires a comprehensive source of documentation including study reports.
It follows the CTD structure developed by ICH and is mandatory to be submitted in the eCTD format starting from May 2018.
The investigational medicinal product dossier (IMPD) is the document of the EU Clinical Trial Application (CTA) used for obtaining the authorization to conduct a clinical trial with an IMP. For the IMPD, it is required a concise high-level summary of quality, manufacture, control of the IMP, data from nonclinical studies, data from clinical use, and the risk and benefit assessment in proposed clinical trials. In some cases, for nonclinical data and clinical use of the IMP, the IMPD cross refers to the IB. Study reports are not mandatory with an IMPD’s submission, but health authorities may request them.
One major difference between IND and IMPD is that with any additional data update with the advancement of the IMP clinical development a new or updated IMPD is submitted with each CTA while the new data can be provided as attachment of the existing IND.
BBCR is experienced in overcoming the challenges of writing INDs and IMPDs. Call us at (617) 401-2327 or contact us by clicking below for a free consultation.
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.