The Investigational Medicinal Product Dossier (IMPD) is a document containing information about an investigational medicinal product (IMP) to be marketed in the EU. It includes various summaries of information related to the quality, manufacture and control of an IMP (including reference product and/or placebo), data from non-clinical studies and from its clinical use, and the product’s developmental phase.
The IMPD is divided into four sections which summarizes the relevant information on quality, pre-clinical, clinical studies, including critical analyses of the non-clinical and clinical data related to the possible risks and benefits of the proposed study, as well as any available previously generated human data and an assessment of the overall risk/benefit. The data is logically structured, and it normally follow the headings of the Common Technical Document (CTD) with the amount of information contained, therefore being dependent on various factors such as product type, indication and development phase. However, vital biopharmaceutical products such as vaccines, antibodies and advanced therapy medicinal products (ATMPs) have additional data requirements.
Investigator’s Brochure (IB) stands as one of the important documents for clinical trial applications (CTAs) which includes part of the data to be presented in the IMPD. Referring to the IB for the preclinical and clinical sections, the IMPD can be prepared. IMPD not only forms the basis for CTA approval but also forms the basis for the CTD to support future marketing authorisation application (MAA). The informative value of the IMPD contributes to the success of drug development programmes and licensing procedures.
What is the format of an IMPD?
On the section headings to be used in a full IMPD, applicants can take clues from the industry guidance, although the format is not obligatory. The IMPD can also follow the structure of a CTD. It is not necessary that IMPD be a large document as the amount of information to be contained in the dossier is dependent on various factors such as product type, indication, development phase etc. If limited or no data is provided within the technical headings, then it must be properly justified. Few vital products such as vaccines, antibodies and gene therapy, are also covered by other EU guidelines and have additional data requirements.
Freyr has a proven record of preparing IMPDs resulting in swift acceptance of CTAs by competent authorities. If you would like to streamline the process for quick approval of your CTA and to know more on missing or misleading information in your IMPD, reach us at firstname.lastname@example.org