Investigational Medicinal Product Dossier (IMPD)

Introduction to the Investigational Medicinal Product (IMP)

An Investigational Medicinal Product (IMP) refers to a pharmaceutical form of an active substance or placebo tested or used as a reference in a clinical trial. This could include a new drug being tested for safety and efficacy in humans, an existing drug tested for a new medical condition, or an existing drug used in a new way, such as with a new dosage or method of delivery.

What is a Clinical Trial Application (CTA)?

A Clinical Trial Application (CTA) is a submission to the competent National Regulatory Authorities for obtaining authorization to conduct a clinical trial in a specific country. It includes necessary information on investigational medicinal products. In the U.S., this is equivalent to an Investigational New Drug (IND) application.

Role and Importance of the IMPD in Clinical Trials

The Investigational Medicinal Product Dossier (IMPD) is crucial for obtaining approval for clinical trials involving Investigational Medicinal Products (IMPs) in the European Union. It is the main document of the CTA in the EU and includes summaries of information related to the quality, manufacture, control of any IMP, data from non-clinical and clinical studies.

Understanding the IMPD

The IMPD gathers several pieces of IMP-related data required when conducting a clinical trial in one or more EU Member States. It contains detailed information about the quality, manufacture, and control of the IMP, including the reference product and placebo, and data from non-clinical and clinical studies.

Guidance and Format of the IMPD

Regulation (EU) No 536/2014, which governs Clinical Trials on Medicinal Products for Human Use, aligns the IMPD guidance. This regulation aims to harmonize the laws, regulations, and administrative provisions across EU Member States concerning the implementation of Good Clinical Practice (GCP) in clinical trials.

Different Types of IMPDs: Full and Simplified

The guidance permits adaptation of the IMPD content based on the existing knowledge about the product and its stage of development. A full IMPD is necessary when the IMP is new and little to no prior information has been submitted to regulatory authorities. A simplified IMPD is acceptable when the information about the IMP has already been evaluated as part of a Marketing Authorization in any EU Member State.

Example Scenarios

Full IMPD: For a new oncology drug targeting a previously untargeted cancer pathway, a full IMPD would include extensive non-clinical data and detailed manufacturing information.

Simplified IMPD: For an additional study of an approved antidepressant, a simplified IMPD would reference existing data from the drug's marketing authorization dossier.

Using SmPC as IMPD

In certain cases, the Summary of Product Characteristics (SmPC) of a marketed product can serve as the IMPD. This is applicable when the IMP has a Marketing Authorization in any EU Member State and is being used in clinical trials in the same form, for the same indication, and within the dosing regimen specified in the SmPC.

Conclusion

The IMPD is a foundational document in the drug development process, providing comprehensive information necessary for evaluating the safety and efficacy of investigational drugs. Its thorough preparation is crucial to ensure compliance with regulatory requirements and to support successful clinical trial outcomes.