D2. Investigational Medicinal Product Dossier (IMPD)
An Investigational Medicinal Product Dossier (IMPD) contains data on the quality, production and control of the medicinal product being researched. The IMPD consists of 2 parts:The IMPD consists of 2 parts:
- The Quality section with information on the active medicinal product, placebo and reference medicine (if applicable).
- The Safety and Efficacy section with a summary of data from all clinical and non-clinical studies, with an overall assessment of the risks and benefits. For this part, reference can also be made to the Investigator's Brochure (IB).
Templates for these two parts of the IMPD are available. The template IMPD can also be used for medicinal products used for advanced therapies (ATMPs).
The requirements of the IMPD are mentioned in paragraph 2.7 of the CT-1 directive ‘Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial’. See also the template Investigational Medicinal Product Dossier (IMPD) and the accompanying explanatory notes.
If a product is authorised and will be used in the licensed form, an SPC (summary of product characteristics) will suffice, if it is available. SPC texts for many medicinal products (summary product characteristics, IB-1 text) may be found in the Medicines Information Bank of the Medicines Evaluation Board.
It is important that the research file for the review committee contains sufficient information on the medicinal product being used in the research so that it can reach an informed decision on the safety and vailidity of the research. Table 1 states the minimum information on the medicinal product which you must submit for review.
If the review committee has already assessed an earlier version of the IMPD in the context of another clinical trial, please state this in the cover letter and submit a summary of changes and a track changes version of the IMPD.