An investigational medicinal product (IMP) is a pharmaceutical form of an active substance or placebo that is being tested or used as a reference in a clinical trial. These products are under investigation to determine their safety, efficacy and optimal use in treating or preventing medical conditions. IMPs can include new drugs, new combinations of existing drugs, or existing drugs used in new ways.
Role in Clinical Trials
IMPs are central to clinical research, where they undergo rigorous testing in human volunteers or patients to gather data on their effects. This process helps regulatory authorities decide whether the product should be approved for wider use. Throughout the trial, IMPs are handled according to strict protocols to ensure participant safety and data integrity.
Regulatory Oversight
The use of IMPs is governed by regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK or the Food and Drug Administration (FDA) in the US. These agencies oversee the approval of clinical trial applications and monitor compliance with safety standards.
Summary
Investigational medicinal products are drugs or placebos tested in clinical trials to evaluate their safety and effectiveness. They are vital for advancing medical knowledge and developing new treatments under strict regulatory control.
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