Investigational Medicinal Product Dossier (IMPD) – Overview

To administer an Investigational Medicinal Product (IMP) to human subjects in EU countries, sponsors must submit a Clinical Trial Authorization (CTA) application, along with an Investigational Medicinal Product Dossier (IMPD) that contains detailed scientific information on the IMP.

Key challenges in conducting clinical trials in the EU include:

• Strategically planning IMPD submissions in all applicable member states where clinical trials are intended.
• Coordinating clinical material manufacturing, GMP compliance, QP release, and import logistics with IMPD submission and trial execution.
• Planning IMPD submissions in compliance with the new EU Regulation No. 536/2014.
• Executing trials across multiple sites and member states, and managing subsequent updates/reporting to the IMPD.

Preparation of a compliant IMPD requires specialized Regulatory expertise to navigate complex submission requirements for diverse product types. Sponsors benefit from consulting a Regulatory partner with experience in EU submissions and IMPD management.
X Pharma Plus provides comprehensive support in the preparation and submission of CTA applications and IMPDs for various medicinal products, including new drugs, recombinant proteins, vaccines, and stem cell-based products, ensuring smooth execution and Regulatory compliance.