What is an Investigational Medicinal Product Dossier (IMPD)? A Guide to the Investigational Medicinal Product Dossier
Regulatory documentation is crucial in ensuring safety and effectiveness of the new medicines in the complicated world of drug development and clinical research. The IMPD, or the Investigational Medicinal Product Dossier is one of those key documents in the European clinical trial system.
Purpose of the Investigational Medicinal Product Dossier (IMPD)
The main aim of the IMPD is to ensure that regulators and ethics committees have enough information to determine the quality, safety, and efficacy of the investigational drug before it is used in human beings. This dossier accompanies the Clinical Trial Application (CTA) and establishes that the clinical trial complies with the high regulatory standards of protecting patients and scientific soundness.
What is Included in an Investigational Medicinal Product Dossier (IMPD)?
The IMPD content is organized into three sections:- Quality Data The chemical, pharmaceutical and biological qualities of the research product are reported in this section. It encompasses details about the composition of the drug, manufacturing, quality control, data on stability and packaging.
- Non-Clinical Data This section outlines all the preclinical research: pharmacology, toxicology, and pharmacokinetics. It evidences the safety profile of the IMP through laboratory and animal testing prior to human testing.
- Clinical Data In this section, all available clinical data before clinical trials, clinical trial outcomes, human pharmacokinetics, safety and efficacy are summarized. This chapter assists regulators to determine the drug functionality in humans and the justification of the proposed clinical trial.
Why is the Investigational Medicinal Product Dossier (IMPD) Important?
The IMPD is a regulatory pillar in the EU regarding clinical trials of investigational drugs. It assists in maintaining:- Patient Safety: Through adequate evaluation of the risks and benefits of the IMP prior to subjecting the volunteers or patients.
- Regulatory Compliance: It is in line with the European Medicines Agency (EMA) and the local regulations.
- Transparency: Gives an understandable, systematic description of the IMP, assisting the regulatory authorities and the ethics committees to later make informed decisions.
- Effective Trial Approvals: Good IMPD helps in quick approval of clinical trials.
How Does the IMPD Relate to Other Documents?
Although the IMPD is unique to the EU clinical trial procedure, other regions might employ comparable documents with various labels, including the Investigational New Drug (IND) application in the United States. These differences are crucial to the planning of multinational clinical trials.
Investigational Medicinal Product Dossier (IMPD) and Masuu Global
Masuu Global are experts in assisting pharmaceutical and biotech companies to produce quality regulatory documents including IMPDs to serve the rigorous needs of the EMA and other regulatory agencies. With our experience in clinical trial submissions, we offer the assurance that your dossiers are complete, conform, and will be ready to achieve approvals.
The IMPD is a document of significant regulatory content that expounds the safety and efficacy of new medicines throughout the EU development. The success of a clinical trial necessitates understanding and getting the IMPD ready right, whether you are a sponsor, CRO, or a pharmaceutical company.
Whether you are dealing with hurdles in clinical trial documentation and regulatory submission, Masuu Global is at your service as your compliance and drug development specialist.
