IMPD

The investigational medicinal product dossier (IMPD)  is a comprehensive regulatory document crucial in pharmaceutical drug development. It provides detailed information about an investigational medicinal product (IMP) being tested in clinical trials, specifically for approval in the European Union.

The IMPD serves multiple critical functions:

• Comprehensive Product Overview: Presents a thorough summary of the investigational medicinal product
• Regulatory Submission: Required for obtaining approval for clinical trials
• Safety and Efficacy Documentation: Includes data on quality, manufacturing, non-clinical and clinical studies

The IMPD is essential because it:

• Helps regulatory authorities evaluate the safety and potential efficacy of investigational drugs
• Forms the basis for Clinical Trial Application (CTA) approval
• Contributes to future marketing authorization applications

The document’s complexity and depth depend on factors like product type, indication, and development phase, with some specialized products like vaccines and advanced therapy medicinal products requiring additional detailed information

The format of the dossier should follow the standard headings of the Common Technical Document (CTD) and applicable European guidelines.

The document’s complexity and depth depend on factors like product type, indication, and development phase, with some specialized products like vaccines and advanced therapy medicinal products requiring additional detailed information.

A simplified IMPD may be submitted if information related to the IMP has been previously assessed as part of a MA in any EU MS or as part of a CTA to the concerned competent authority.