This Implementing Regulation is composed of 3 Sections divided into 19 articles and 1 Annex. Section I defines tasks and competencies of the National Authority for Research and Control of Biological Medicines in particular to: control all biological preparations, vaccines and serums; carry out technical evaluation of clinical studies for verification side effects, safety and effectiveness of products; verify and examine scientific publications related biological preparations; monitor cases of adverse effects that might arise from vaccinations and data collection to find out why they occur; and, create a database for vaccines and serums in Egypt and their standards. Section II deals with general divisions of research, and offices of control and management. Section III deals with scientific researchers and the Authority staff as well as the management and internal organization of the Authority. Annex I contains scientific careers equivalence in the Authority.
Egypt · 2009-07-07