The Laboratory Services Directorate provides scientific testing, analysis, and evaluation services to support regulatory decision-making and ensure the quality, safety, and efficacy of regulated products. The laboratory conducts analytical testing of medicines, vaccines, medical devices, cosmetics, and other regulated products to verify compliance with established quality standards.   The Directorate plays a critical role in […]

The Monitoring the Safety of Medicines programme is responsible for the continuous assessment and monitoring of the safety of medicines after they have been authorized for use. Through pharmacovigilance activities, ZAMRA collects, evaluates, and responds to reports of adverse drug reactions, medication errors, product quality issues, and other medicine-related safety concerns. The programme works closely […]

The Cosmetic Regulation Directorate is responsible for overseeing the registration, importation, distribution, and marketing of cosmetic products in Zambia. The Directorate ensures that cosmetic products available on the market comply with applicable regulatory requirements and do not pose risks to consumer health when used as intended.   The Directorate evaluates product information, ingredient composition, labeling […]

The Veterinary Regulation Directorate oversees the regulation of veterinary medicines and animal health products to ensure they meet standards of quality, safety, and efficacy. The Directorate is responsible for the evaluation, registration, licensing, importation, and post-market surveillance of veterinary medicinal products used in the prevention, diagnosis, and treatment of animal diseases. By regulating veterinary products, […]

The Clinical Trials Regulation Directorate is responsible for the review, authorization, and oversight of clinical research involving medicines, vaccines, medical devices, and other regulated products. The Directorate ensures that clinical trials conducted in Zambia adhere to national legislation, ethical principles, and internationally accepted standards of good clinical practice. The Directorate evaluates study protocols, investigator qualifications, […]

The Medical Devices Regulation Directorate is responsible for the regulation of medical devices and in-vitro diagnostic devices intended for use in the diagnosis, prevention, monitoring, treatment, or alleviation of diseases and medical conditions. The Directorate ensures that medical devices placed on the Zambian market are safe, effective, and perform as intended. The Directorate reviews applications […]