National Centre for Expertise of Medicines and Medical Devices

Company profile

National Centre for Expertise of Medicines and Medical Devices company profile

National Center for Expertise of Medicines and Medical Devices performs scientific and regulatory assessments for pharmaceuticals, biologics, and medical devices. The organization conducts pre- and post‑registration expertise, including dossier evaluation, laboratory testing, and quality control. It manages state registration processes, renewals, and variations for medicinal products and devices, and maintains reference standards and pharmacopeial testing methods. Pharmacovigilance activities include safety monitoring, signal detection, and adverse event processing across the product life cycle. The center reviews clinical and nonclinical evidence within regulatory submissions for medicines and devices. Information systems provide public registries, databases of authorized products, and guidance documents for market participants. Training and methodological support help manufacturers, distributors, and healthcare institutions comply with regulatory and quality requirements.