What Is an IMPD?
Understanding the Investigational Medicinal Product Dossier
Regulatory approval is a pre-requisite prior to initiating any clinical trial that involves any medicinal products in the European Union. Among the most significant papers needed in this procedure is Investigational Medicinal Product Dossier (IMPD). The IMPD offers the regulatory authorities comprehensive information to assess the quality, safety and clinical use of an investigational medicinal product.
An Investigational Medicinal Product Dossier (IMPD) is a major regulatory document which is part of a Clinical Trial Application (CTA). It includes scientific and technical information concerning the investigational medicinal product (IMP), so that it is fit to use in human clinical research.
The IMPD will allow the regulators and ethics committees to determine the possibility of risks and ensure that the relevant controls are established to safeguard trial subjects.
Why Is an IMPD Required?
The Investigational Medicinal Product Dossier is necessary to prove:- Quality of products and consistency of manufacturing.
- Non-clinical and clinical based safety.
- Rationale of the dose and trial design proposed.
- Conformity to Clinical Trial Regulation of the EU (EU CTR 536/2014).
- Without an approved Investigational Medicinal Product Dossier , clinical trials cannot legally proceed in the EU.
Key Components of an Investigational Medicinal Product Dossier
Quality (CMC) Section Provides details of drug substance and drug product manufacturing, specifications, stability data, packaging, and labeling. Non-Clinical Section Overviews pharmacology, toxicology, and pharmacokinetic research that can be used to support safe human exposure. Clinical Section Gives accessible human information, such as previous clinical experience, safety results, and rationale.How Masuu Global Can Help
Masuu Global provides professional support in IMPD writing, reviewing, and submission to the regulatory authority, and complying with the changing regulations in the EU and quicker approvals of clinical trials.