Establishment of the EDA

The Egyptian Drug Authority (EDA) was established per Law No. 151 of 2019 issued on 25 August 2019, and then the Prime Minister issued Decision No. 777 of 2020 issuing the executive regulations of the law establishing the EDA on 29 March 2020.

The Authority's objectives

• The Authority aims to organize, implement, and monitor the quality, effectiveness, and safety of pharmaceuticals and medical devices stipulated in the provisions of the Law establishing the Authority, and the raw materials that go into their manufacture, and in particular, it has the following:

• Establishing policies, rules, and procedures governing everything related to organizing, implementing, and monitoring the production and circulation of pharmaceuticals, medical devices, and raw materials, and verifying their quality, effectiveness, and safety inside and outside the Republic, in coordination with the concerned ministries and authorities, by international standards and applicable rules.

• Developing and ensuring the quality, effectiveness, and safety of pharmaceuticals, medical devices, and raw materials that are used in diagnosis, treatment, or prevention per the latest scientific developments.
• Developing and updating accurate databases on everything related to pharmaceuticals, medical devices, and raw materials stipulated in the law and this regulation.
• Spreading proper awareness and pharmaceutical education to all segments of society, and working by all means to communicate health messages and documented information about pharmaceuticals and medical devices to specialists and the public.
• Organizing and monitoring the production and circulation of pharmaceuticals and medical devices stipulated in the law and verifying their quality, effectiveness, and safety inside and outside the Republic within the framework of the control of Egyptian products and the quality of representation abroad.
• Proposing and expressing opinions on all draft laws, regulations, and decisions related to pharmaceuticals, medical devices, and raw materials, as well as related regulatory matters.
• Cooperate, coordinate, and exchange information with national and international organizations and authorities concerned with pharmaceuticals and public health and those competent to issue relevant standards, and participate in and organize local and international conferences, within the scope of achieving the Authority's objectives and following the various rules and procedures followed in this regard.

Competencies of the Authority

First: Regulatory Competencies

The Egyptian Drug Authority shall carry out the following organizational competencies: 

• Develop policies and plans that aim to ensure the availability, quality, effectiveness, and safety of pharmaceuticals and medical devices, in coordination with the concerned ministries and agencies.
• Review and amend all regulatory systems, regulations, and decisions related to its field of work to develop them in line with quality and health safety requirements and international standards, and may propose necessary amendments or new rules and provisions in systems, regulations, and decisions that fall outside its competences, provided that these proposals are referred to the competent authorities for studying and issuance following the established methods and procedures.
• Establishing the rules, sound principles and technical and health requirements to be met by pharmaceutical establishments and their employees.
• Coordinate with the General Authority for Industrial Development to set the controls for allocating land for pharmaceutical factories, medical devices, and raw materials, as well as coordinate with it in setting the requirements for granting licenses for pharmaceutical factories, medical devices, and raw materials subject to the provisions of the law by the applicable standards, to ensure the speedy issuance of final licenses, and develop joint mechanisms to ensure cooperation in all of the above to ensure the proper functioning and regularity of work and the achievement of the public interest.
• Establish controls and requirements for the licensing of laboratories and verification of technical requirements and procedures for conformity, quality assurance, efficacy, and safety of pharmaceuticals and medical devices subject to the provisions of the law; as well as requirements and procedures for the accreditation of their results.
• Establishing controls and procedures that regulate the inspection of pharmaceuticals and medical devices subject to the provisions of the law and the raw materials that go into their manufacture.
• Establish controls and procedures that regulate the import, export, registration, circulation, control, and inspection of pharmaceuticals and medical devices subject to the provisions of the law, raw materials that enter into their manufacture, and production tools, in coordination with the relevant authorities and by international standards, as well as establishing controls and procedures that regulate the pricing of any medical or biological preparations or medical supplies subject to the provisions of the law.
• Developing binding systems that ensure the quality, effectiveness, and safety of pharmaceuticals and medical devices subject to the provisions of the law and the raw materials that go into their manufacture, tracking and following them through all stages of circulation, and applying these systems to all entities involved in this process, including manufacturers, importers, and distributors of these products, as well as those related to their circulation and taking the necessary measures to withdraw the product from circulation, and these systems and all matters related to the environmental tracking system are issued by a decision of the Chairman of the Board of Directors of the Authority after approval by the Board of Directors.
• Preparing and developing training programs to raise the efficiency of workers in the field of the Authority's work, whether inside or outside the Authority.

Second: Executive Competencies

The Egyptian Drug Authority is responsible for implementing the laws, regulations, regulatory decisions, controls, and procedures governing the registration, pricing, circulation, and control of pharmaceuticals and medical devices subject to the provisions of the law and the raw materials that enter into their manufacture, and following up on the application of related procedures to ensure consumer protection and take legal action before violators, and in particular, to take the following measures:

• Issuing licenses for various types of pharmaceutical establishments per the provisions of Law No. 127 of 1955 and the Law on Facilitating the Granting of Licenses for Industrial Establishments referred to therein. The Authority is competent to issue technical licenses for operation only and ensure the application of good manufacturing requirements without the rest of the licensing procedures for factories for the production of pharmaceuticals, medical devices, and raw materials and to ensure rapid coordination for the issuance of final licenses.
• Evaluating pharmaceuticals and medical devices subject to the provisions of the law, and pricing medical and vital preparations following the rules, standards, and controls approved by the Board of Directors of the Authority.
• Examine and analyze medical, vital, and veterinary preparations, herbal medicines, plant extracts, pharmaceutical products, cosmetics, and everything that falls within their scope according to international standards and references to verify their quality, effectiveness, safety, conformity with pharmacopeias and conformity with the mandatory standard specifications approved by the Authority.
•  Examine and analyze medical devices, glasses, contact lenses, and electronic devices that have an impact on public health and verify their quality, effectiveness, safety, and conformity with the mandatory standards approved by the Authority.
• Examine and analyze laboratory and diagnostic reagents to verify their quality, effectiveness, safety, and conformity with the mandatory standard specifications approved by the Authority.
• Examine and analyze pesticides and disinfectants to verify their quality, effectiveness, safety, and conformity with the mandatory standard specifications approved by the Authority.
• Allowing the circulation of locally manufactured pharmaceuticals and medical devices subject to the provisions of the law and others that fall within the Authority's jurisdiction, after carrying out the necessary tests and analyses per the procedures approved by the Authority.
• Releasing imported pharmaceuticals and medical devices subject to the provisions of the law and everything related to the Authority's field of work, after carrying out the necessary tests and analyses following the procedures approved by the Authority.
• Establishing and updating accurate databases in the field of the Authority's work, and exchanging information with local, regional, and international bodies.
• Cooperate with Egyptian and foreign universities and research centers to conduct applied research and studies in everything related to the Authority's field of work.
• Conducting research and studies related to its work and activities, and cooperating with companies, bodies, universities, scientific research centers, and other bodies that carry out similar work.
• Implementing training programs to raise the efficiency of workers in the Authority's field of work, and accrediting bodies that provide training courses and qualification programs for workers in the Authority's field of work.
• Raising consumer awareness regarding pharmaceuticals and medical devices subject to the provisions of the law and everything that falls within the Authority's jurisdiction, and coordinating with relevant authorities and bodies.
• Representing the State in regional and international bodies and organizations in the field of the Authority's jurisdiction.
• Evaluating the results of the different stages of clinical trials of pharmaceuticals and medical devices subject to the provisions of the law and the necessary control procedures on all the different stages and related facilities that fall within the jurisdiction of the Authority, following the rules and procedures determined by the Board of Directors of the Authority and issued by a decision of the Chairman of the Board of Directors.

• By a decision of the Chairman of the Board of Directors of the Authority, after the approval of the Board of Directors, the Authority may establish reference laboratories and testing laboratories at its headquarters that include all its competencies, or establish specialized sub-laboratories to achieve its objectives, and the reference laboratory may provide consultancy services to governmental and private entities following the rules approved by the Board of Directors of the Authority.

Third: Regulatory Competencies

The EDA performs the following regulatory functions:

• Monitoring the application of laws, regulations, regulatory decisions, controls, and procedures for the practice of the activity of pharmaceutical factories, medical devices, and raw materials subject to the provisions of the law, and all that falls within the jurisdiction of the Authority, and ensuring the application of sound principles of good manufacturing, whether inside or outside the Republic, and this is done by adopting the standards and requirements of the World Health Organization for good manufacturing rules and requirements as a scientific reference, as well as other international standards, provided that explanatory and interpretative decisions are issued to suit the nature, requirements, and needs of the Egyptian pharmaceutical market; in line with the standards and
• Control, follow-up, and inspection of all types of pharmaceutical establishments and their employees, and take legal action against violators of the application of standard specifications in production, storage, or circulation, in cooperation and coordination with the relevant authorities.
• Control of pharmaceuticals and medical devices subject to the provisions of the law and everything related to the Authority's field of work to ensure their quality, effectiveness, safety, and conformity of the manufacturer's specifications with the mandatory standard specifications approved by the Authority.
• Control the import, export, distribution, storage, and circulation of pharmaceuticals and medical devices subject to the provisions of the law.
• Monitor and control the harmful effects that may result from the circulation of pharmaceuticals and medical devices subject to the provisions of the law, and take measures to minimize them.
• Periodic follow-up and pharmacovigilance of pharmaceuticals and medical devices subject to the provisions of the law after marketing.