Investigational Medicinal Product (IMP)
Investigational Medicinal Product (IMP) is defined in the Guideline for good clinical practice E6(R2) as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use (EMA/CHMP/ICH/135/1995). Investigational medicinal products should be produced following the principles and the detailed guidelines of Good Manufacturing Practice (GMP) for Medicinal Products and other applicable guidelines published by the European Commission.
The trial sponsor must assure site’s quality of the IMP, bearing in mind the safety of the trial subjects. The IMP to be used in the clinical trial is checked and released by the Qualified Person (QP) to the sites for use in a clinical trial. Moreover, the sponsor must assess the site’s suitability to the nature, storage and use of the IMP. Only then the IMP should be shipped to the site. Then, the sponsor is obliged to assure proper and monitored IMP transport and storage conditions throughout the trial.
The specific form of documentation in this area is an Investigational Medicinal Product Dossier (IMPD) is a document that contains data on the quality, production and control of such product. IMPD should be prepared in line with Appendix 1 of Clinical trials – Regulation EU No 536/2014 and Guideline on the requirements of the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (EMA/CHMP/QWP/545525/2017 Rev. 2). In line with above-mentioned regulations IMPD consists of an introduction, quality section, which contains information on the chemical and pharmaceutical quality of the product and non-clinical pharmacology and toxicology data section presenting results from all non-clinical studies related to product and if available data from previous clinical trials and human experience. A brief integrated summary, with critical analyses of the non-clinical and clinical data should be also provided unless it is already in the study protocol. In case of summaries of pre-clinical and clinical data, IMPD may cross-refer to the Investigator’s brochure for the reference safety information.
If you need support in any actions concerning IMP or IMPD preparation for the purpose of study in the European Union or another ICH (International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) country, contact SciencePharma.
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