In the context of pharmaceuticals and clinical trials IMPD stands for Investigational Medicinal Product Dossier.
An IMPD is a comprehensive document that provides detailed information about an investigational medicinal product. It includes data on the product’s quality, manufacturing, non-clinical studies, and clinical trial plans.
Regulatory authorities require the submission of an IMPD as part of the process for seeking approval to conduct clinical trials with new drugs or therapies.
The Investigational Medicinal Product Dossier 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).
Significance of IMPD
The IMPD serves as a key regulatory submission to health authorities, such as the European Medicines Agency (EMA), when seeking approval to conduct clinical trials with the IMP. Here are some of the key components and information typically included in an IMPD.
If the Investigational Medicinal Product Dossier is approved, it allows researchers to proceed with clinical trials to gather additional data and evidence to support the potential approval of the new medication or therapy for broader use in healthcare.
At Royed Training, we have CMC Writing course covers Investigational Medicinal Product Dossier preparation. Also, both Executive Program in International Drug Regulatory Affairs (EPGIDRA) and PG Certification in Drug Biologic Medical Device Regulatory Affairs (PGDBMRA) course covers IMPD preparation. IMPD and related IMPD writing is exclusively for European Submission. Therefore in European Drug Regulatory Affairs (EUDRA) IMPD topics are covered.