Theo Tiko and Annegret Wiedemann reflect on their experience with most recently prepared IMPDs.
The Investigational Medicinal Product Dossier (IMPD) is a central piece of Investigational Medicinal Product (IMP) related documents required for approval of clinical trials by the competent authorities in the EU. An IMPD is required for IMPs to be used in a clinical study, regardless of whether it is the test product itself, a reference product already authorised or a placebo.
The IMPD is divided in four sections and summarizes the relevant information on quality, pre-clinical, clinical studies, including critical analyses of the non-clinical and clinical data related to the potential risks and benefits of the proposed study, as well as any available previously generated human data and an assessment of the overall risk/benefit. These data are presented in a logical structure and they normally follow the headings of the Common Technical Document (CTD) with the amount of information contained therein being dependent on various factors such as product type, indication and development phase. Special biopharmaceutical products such as vaccines, antibodies and advanced therapy medicinal products (ATMPs) have additional data requirements.
Another important document for clinical trial applications (CTAs) that includes part of the data presented in the IMPD, is the Investigator’s Brochure (IB). Even though a “slimmer” IMPD is possible by cross-referring to the IB for the preclinical and clinical sections, any special aspect that requires detailed expert reports or discussions beyond what is usually included in the IB, should be submitted as part of the IMPD.
It is thus clear that the IMPD not only forms the basis for CTA approval, but through subsequent modifications and amendments by additional knowledge gained, will also form the basis for the CTD to support a future marketing authorisation application (MAA). The informative value of the IMPD significantly contributes to the overall success of drug development programs and, ultimately, licensing procedures. For a first in man CTA, it is the first document to assemble and contextualize all research data obtained up to that point in the CTD format. In addition to competent authorities, potential investors, partners and licensees also perform rigorous reviews of regulatory documentation such as the IMPD. Thus, the value added from the clear, accurate and creatively proactive writing of the IMPD is indispensable through all stages of development.
Biopharma Excellence has a longtime and proven record of writing and assembling IMPDs resulting in swift acceptance of CTAs by competent authorities. If you would like to avoid delay of approval of your CTA due to missing or misleading information of your IMPD please contact us for assistance.