هيئة الدواء المصرية هي هيئة عامة خدمية ذات شخصية اعتبارية تتبع رئيس مجلس الوزراء، تتولى تنظيم وتنفيذ ومراقبة جودة وفاعلية ومأمونية المستحضرات والمستلزمات الطبية المنصوص عليها بأحكام قانون إنشاء الهيئة.

regulations are carried out in Egypt with clear application submission steps at different developmental phases of the investigational medicinal product. This guideline applies to all clinical trials conducted in Egypt that are regulated by the Egyptian Drug Authority according to the Clinical Trials Law no. 214/2020 involving human

The Egyptian Pharmacopoeia is a publication of Egyptian Drug Authority (EDA), and through the establishment of its quality standards, plays a significant role in ensuring the quality of medicines and fostering innovation.

the Egyptian Drug Authority to implement reliance concepts during registration of biological products (i.e. vaccines, plasma derived medicinal products, biotechnology derived, advanced therapeutic medicinal products

Egyptian Drug Authority (EDA) has replaced NORCB and NODCAR through Law No. (151) for year (2019). EDA is engaged in a close collaborative effort with other regulatory

He has a solid background in the field of bio similarity assessment, biomolecular characterization, analysis of biotherapeutics and pharmaceuticals in biological fluids. Dr Al-Ghobashy is currently the director of Drug Control Laboratories at the Egyptian Drug Authority (EDA).

companies’ needs for reference materials, the Egyptian Drug Authority’s accreditation program for reference materials aims to provide a mechanism for certifying and continuously provide the reference materials required for quality control laboratories. to

guideline is intended to facilitate the performance of pharmacovigilance activities in Egypt and applies on marketing authorization holders. The Egyptian Drug Authority has a core role in coordinating these activities. Additionally, the Egyptian legislations imposes responsibility for pharmacovigilance,

Egyptian Drug Authority adopts Good Reliance Practices in the evaluation of safety, efficacy and quality data of human pharmaceutical products registered in stringent Regulatory authorities (SRAs) included in a list of the reference countries approved by the Technical Committee for Drug Control or WHO prequalified to grant the MA

the executive regulations of the law of establishing the Egyptian Drug Authority “promulgated by Prime Minister’s Resolution No. 777 of 2020” and the service fees shall be collected as per the decree issued by