About the Egyptian Drug Authority:
The Egyptian Drug Authority (EDA) is a public service body with legal personality under the Prime Minister. It was established by Law No. 151 of 2019 to replace the National Authority for Pharmaceutical Control and Research and the National Authority for Research and Control of Biological products, as well as several other administrative bodies and entities with competence in the field of control of pharmaceuticals and medical devices.
The EDA is responsible for regulating the registration, circulation, and control of pharmaceutical products and the raw materials used in their manufacture wherever they are mentioned in the relevant laws, regulations, and regulatory decisions.
The Authority is responsible for implementing the laws and regulations related to pharmaceutical products and medical devices subject to the provisions of this law, following up on the application of procedures related to them to ensure consumer protection, and taking legal action before violators, in addition to issuing licenses for various types of pharmaceutical establishments, the Authority is responsible for issuing operating permits only without the rest of the licensing procedures for factories producing pharmaceutical products, medical devices and raw materials subject to the provisions of this law and listed in the definitions in Article (1) of the law establishing the Authority.
The Authority is responsible for licensing private laboratories related to the Authority's field of work and establishing the licensing rules for the same, as well as examining and analyzing pharmaceutical and biological products, plants and herbs with medical claims, cosmetics, and everything that falls within their scope according to international standards and references to verify their quality, validity, effectiveness, safety and security, as well as the conformity of medicines with pharmacopeias and their conformity with the mandatory standard specifications approved by the Authority.
The Authority examines medical devices, glasses, contact lenses, and electronic devices that impact public health and verify their quality, safety, security, effectiveness, and conformity with the mandatory standard specifications approved by the Authority.
The Authority examines and analyses laboratory and diagnostic reagents to verify their quality, safety, effectiveness, and conformity with the mandatory standard specifications approved by the Authority; examines and analyses pesticides to verify their quality, safety,efficacy and conformity with the mandatory standard specifications approved by the Authority; and allows the circulation of locally manufactured pharmaceutical products and medical devices subject to the provisions of this law and others that fall within the competencies of the Authority after carrying out the necessary examinations and analyses.
The EDA releases imported pharmaceutical products and medical devices subject to the provisions of this law and everything related to the Authority's field of work after conducting the necessary tests and analyses, addressing emergencies in the field of medicine, taking appropriate precautions and preventive measures, establishing an information base in the field of the Authority's work, and exchanging information with local, regional and international authorities.
In addition to its competencies stipulated in Law No. 151 of 2019, the EDA is responsible for evaluating the results of pre-clinical and clinical medical research, conducting scientific reviews of the pharmaceutical or biological products before starting clinical medical research, assessing the research plan and amendments thereto, reviewing the documents related to the products subject to medical research to ensure good practice for manufacturing, handling and preservation, as well as inspecting the research bodies where clinical medical research is conducted and related parties, to verify good medical practice.