The Investigational Medicinal Product Dossier (IMPD): Essential CTA Document and Guide for Your Biopharmaceutical Development Program
MF BIOTECH has a proven track record in writing IMPDs that enabled a smooth CTA review process across all development stages, especially for complex biopharmaceuticals.
The Investigational Medicinal Product Dossier (IMPD) is one of the essential documents for a clinical trial application (CTA) in the EU. Especially prior to initiating clinical development, the preparation of an IMPD may take some effort because it is typically the first time that all development data generated to date are summarized in a comprehensive manner for the review by competent authorities. The IMPD may also serve as critical documentation during due diligences with potential investors and cooperation partners.
IMPD STRUCTURE
The IMPD consists of four parts: quality, pre-clinical, clinical data, and the assessment of overall risk benefit. It is possible to cross-reference to the Investigator’s Brochure (IB) if the information is already included there.
The structure of each IMPD part is closely aligned with the headings of the Common Technical Document (CTD) which also is the structure of dossiers for marketing authorization applications. Therefore, the IMPD sets the very early basis of the future dossier.
In the case of complex biopharmaceuticals, the IMPD structure and the allocation of available data must be accurately planned out so that the information can be easily located and presented in a clear manner (e.g. cell and gene therapies without a defined drug substance).
CONNECTING IMPD WRITING AND DEVELOPMENT STRATEGY
The IMPD summarizes and organizes available development data including key conclusions and provides reference and context to applicable regulatory guidelines and other scientific aspects taken into account during development. Overall, the development strategy is concisely reflected in the storyline of the IMPD.
When writing and compiling the IMPD, it is common that additional development questions may arise requiring further justification or mitigation strategies, for example if data are incomplete or deviations from regulatory guidelines occurred. IMPD writing facilitates to address these issues by:
Clear presentation of available data and information
Accurate and appropriate language for reviewers
Making best use of the available regulatory framework
Providing scientific-technical considerations and justifications, as needed
Cross-functional collaboration
Proactively anticipating questions from regulators avoiding delays during the CTA review
Augmenting and refining strategic considerations of the development program.