General Overview:

• Evaluation and registration of  biological and innovative products after ensuring their safety, quality, and efficacy, before they are circulated and introduced into the local or foreign market. This is done during the stages of registration of  these products, as well as post registration (release of batches - variation - re-registration). 

• Evaluation of protocols and periodic follow-up and GCP inspection for all clinical studies related to biological, pharmaceutical , innovative products, herbal medicine and medical devices conducted in the Arab Republic of Egypt and evaluation of their results, as well as evaluation of clinical and pre-clinical studies submitted for registration of biological and innovative products. 

• Providing technical support to companies regarding biological and innovative products, as well as clinical and pre-clinical studies in accordance with national and international regulations. 

• Issuing regulatory guidelines and Notice To Applicants for biological and innovative products, as well as clinical and pre-clinical studies, in accordance with national and international regulations and  standards for good practice.