Investigational Medicinal Product (IMP)

Investigational Medicinal Product (IMP) refers to a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products with marketing authorisation when used outside approved indications. IMPs include small molecules, biologics, vaccines, and advanced therapy products, requiring appropriate labelling, handling, and documentation to ensure correct use and traceability.

The biopharmaceutical industry maintains strict IMP processes to meet regulatory expectations and protect patient safety. IMP manufacturing typically follows GMP requirements appropriate for clinical stage, with batch release testing confirming quality attributes and stability. Clinical supply chains manage packaging, labelling, temperature-controlled distribution, and site-level storage. Accountability procedures track dispensing, returns, and destruction to prevent errors. Blinded trials require specific measures ensuring randomisation integrity. As trials become global and increasingly complex, IMP management systems integrate digital tracking, risk-based oversight, and robust quality frameworks ensuring reliable trial execution.