Medicines for Human Use
The Medicines for Human Use section is responsible for the regulation of pharmaceutical products intended for the prevention, diagnosis, treatment, mitigation, or cure of diseases in humans. The Authority ensures that all medicines placed on the Zambian market meet internationally recognized standards of quality, safety, and efficacy before they are approved for use.
This section oversees the evaluation and registration of medicines, review of product dossiers, assessment of manufacturing processes, and monitoring of products after they have been placed on the market. Through pharmacovigilance activities and post-market surveillance, ZAMRA continuously monitors the safety and effectiveness of medicines to protect public health.
The section also provides guidance to applicants, pharmaceutical companies, healthcare professionals, and other stakeholders on regulatory requirements relating to human medicines.