Overview

An Investigational Medicinal Product (IMP) is a pharmaceutical form of an active substance which is to be tested / to be used as reference in a clinical trial. The Investigational Medicinal Product Dossier (IMPD) is a support document providing information on the quality, manufacturing and control of the IMP, non-clinical studies conducted with the IMP, clinical use of the IMP, and the overall risk / benefit assessment of the IMP in the proposed trial.

An IMPD is one of the essential documents that form the clinical trial application (CTA) submitted to competent authorities of EU member states for non-authorized IMPs. Where an IMP is subject of a marketing authorization, the Summary of Product Characteristics in addition to other necessary data can be submitted in lieu of the IMPD. The challenge lies with conducting clinical trials in multiple member states, trial execution in multiple sites and subsequent reporting/updates to IMPD.

Hands on experience in EU Regulatory submissions and handling IMPD applications will help in optimal planning of Regulatory submission and smooth execution of trial related logistics for complex clinical programs. Also, with the proposed implementation of new clinical trial regulation 536/2014 expected to be effective in 2019, the way clinical trials are conducted in the EU is expected to undergo a major change. Compilation of different phases of IMPDs in compliance with EU-specific Regulatory requirements and managing the Regulatory hurdles for different types of products (New molecular entity, precision therapy medicines, recombinant protein products, vaccines, stem cell-based products etc.) require proven Regulatory expertise.

Freyr assists manufacturers in handling and submission of IMPDs for different types of medicinal products. Apart from professional advice to appoint qualified person (QP) for Good Manufacturing Practices (GMP) Freyr supports in compilation and submission of updates / amendments to IMPDs.

 

Freyr Expertise

  • Strategic support in identifying the optimal Regulatory submission pathway for conducting clinical trials in multiple member states as per the proposed clinical program
  • Expert advice on mitigation plan for product developmental issues/ submission risks
  • Gap analysis of developmental data/ source data against current EU Regulatory requirements for IMPD submission/ conducting human clinical trials; and to locate Regulatory deficiencies and recommend submission strategy to mitigate them if found
  • Extensive understanding on MAA registration requirements and guidelines
  • Compilation, technical review and submission of IMPDs for different types of medicinal products (pharmaceutical products, vaccines, biosimilars and other biological products like cell culture and gene therapy products etc.)
  • Advice for appointment/consultation of QP to address GMP related issues and for release of clinical lots
  • Follow-up with Regulatory agencies as needed for the clinical trial program
  • Regulatory response strategy, preparation and on-time response submission to Health Authority (HA) queries
  • Regulatory strategic support in addition to compilation and submission of updates /  amendments to IMPDs