The European Investigational Medicinal Product Dossier is a document used to support the investigational use of a medicinal product in clinical trials within the European Union (EU). It is similar to the scientific part of US IND (Investigational New Drug) application. The sponsor is responsible for the content of the EU IMPD and for ensuring that it is kept up to date throughout the clinical trial.
What is included in an IMPD?
The IMPD includes summary data on the quality of the manufacturing and management of the Investigational Medicinal Product – IMP (including references and placebos).
The EU IMPD must include the background information on the quality, nonclinical and clinical development of the investigational product up to the clinical trial. Nonclinical and clinical parts are very often a cross-reference to the Investigator Brochure data.
How BlueReg can help you all along your drug development program?
- Registration strategy for clinical trials in Europe
- Writing IMPD and RtQ
- Support for CTA (Clinical Trial Application) preparation and submission (as per CTD – Clinical Trials Directive or new CTR – Clinical Trials Regulation), including requirement by countries : Writing protocol, Investigational Brochure
- Associated scientific advice : BP writing / procedure
- CSR (Clinical Study Reports) writing and declaration to EU database
What is IND and IMPD?
IND (Investigational New Drug) and IMPD are regulatory documents submitted to Competent Authority (IND to FDA, IMPD to EMA) for an investigational medicinal drug for approval to begin human clinical trials.
US Investigational New Drug (IND) is an equivalent of the European Clinical Trial Application (CTA) whereas the IMPD is a document which is part of the CTA.
What is an IMPD in drug development?
This document identifies all quality, nonclinical and clinically relevant information for approval by a Regulatory Authority of the European Union for a drug product in an investigation.