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Pharmacovigilance and Safety Reporting: Practical Guidance for Category A Clinical Trials with Investigational Medicinal Products

Category A clinical trials on Investigational Medicinal Products (IMPs) are low-risk studies using authorised medicines within their approved indication, dosage, and population. They require Ethics Committee approval and must comply with safety reporting obligations under both the Clinical Trials Ordinance (ClinO) and the Therapeutic Products Act (TPA). This guidance outlines the key regulatory requirements and reporting procedures for these trials.