Central Administration for Biological Products, Innovative Products, and Clinical Studies
Central Administration for Biological Products, Innovative Products, and Clinical Studies
Evaluation and Registration: Assess and register biological and innovative products, ensuring their safety, quality, and efficacy before their market release, whether locally or internationally. This includes evaluating products during registration phases as well as post-registration phases (e.g., batch releases, variations, re-registration).
Clinical Study Evaluation: Review and monitor all clinical studies related to biological and pharmaceutical products conducted in Egypt, including assessing their protocols and results. Evaluate clinical and pre-clinical studies submitted for registration.
Technical Support: Provide technical support to companies to complete the registration process in accordance with local and international regulations.