A public service authority with a legal personality affiliated to the Prime Minister
Establishment of the Commission
The Egyptian Drug Authority was established in accordance with Law No. 151 of 2019 issued on August 25, 2019, and then the Prime Minister issued Resolution No. 777 of 2020 issuing the executive regulations of the law establishing the authority on March 29, 2020.
Objectives of the Commission
The Authority aims to regulate, implement, and monitor the quality, effectiveness and safety of medical preparations and supplies stipulated in the provisions of the law establishing the Authority, and the raw materials involved in their manufacture, and in particular the following:
Setting policies, rules and procedures governing everything related to the organization, implementation and control of the production and circulation of medical preparations and supplies and raw materials, and verifying their quality, effectiveness, and safety inside and outside the Republic, in coordination with the ministries and bodies concerned, in accordance with international standards and rules in force.
Developing and ensuring the quality, effectiveness and safety of medical preparations and supplies and raw materials used in diagnosis, treatment or prevention in accordance with scientific developments.
Develop and update accurate databases on everything related to medical preparations and supplies and raw materials stipulated in the law and this regulation.
Spreading correct awareness and drug education to all segments of society and working by all means to deliver health messages and documented information about medical preparations and supplies to specialists and the public.
Organizing and controlling the production and circulation of medical preparations and supplies stipulated by law and verifying their quality, effectiveness, and safety inside and outside the Republic within the framework of monitoring Egyptian products and the quality of representation abroad.
Proposing and expressing an opinion on all draft laws, regulations and decisions related to medical preparations and supplies and raw materials, as well as related regulatory matters.
Cooperating, coordinating, and exchanging information with national and international organizations and bodies concerned with pharmaceuticals, public health and those concerned with issuing the relevant standards, and participating in and organizing local and international conferences, within the scope of achieving the objectives of the Authority and in accordance with the various rules and procedures followed in this regard.
Competences of the Commission
First: Regulatory Competencies
The Egyptian Drug Authority undertakes the following regulatory competencies:
Develop policies and plans aimed at ensuring the availability of medical preparations and supplies and ensuring their quality, effectiveness, and safety, in coordination with the relevant ministries and agencies.
Review and amend all regulatory systems, regulations and decisions related to its field of work with the aim of developing them to keep pace with the requirements of quality, health safety and international standards, and it may propose the necessary amendments or propose the development of new rules and provisions in the laws, regulations and decisions that are outside its competences, provided that these proposals are referred to the competent authorities for study and issuance in accordance with the methods and procedures in force.
Setting the proper rules and foundations and technical and health requirements that must be met in pharmaceutical facilities and their employees.
Coordination with the Industrial Development Authority to set controls for the allocation of land for factories, preparations, medical supplies and raw materials, as well as coordination with it in setting the requirements for granting licenses for factories of preparations, medical supplies and raw materials subject to the provisions of the law in accordance with the applicable standards, and in a manner that ensures the speedy issuance of final licenses, with the development of joint mechanisms to ensure joint cooperation in all of the above to ensure the proper functioning and regularity of work and achieve the public interest.
Setting the controls and requirements for licensing laboratories and bodies verifying technical requirements, conformity procedures and ensuring the quality, effectiveness and safety of medical preparations and supplies subject to the provisions of the law, as well as the requirements and procedures for approving their results.
Setting the controls and procedures that regulate the examination of medical preparations and supplies subject to the provisions of the law and the raw materials used in their manufacture.
Setting the controls and procedures that regulate the process of import, export, registration, circulation, control and inspection of medical preparations and supplies subject to the provisions of the law, the raw materials used in their manufacture, and production tools, in coordination with the relevant authorities and in accordance with international standards, as well as setting the controls and procedures that regulate the pricing process of any of the medical or biological preparations or medical supplies subject to the provisions of the law.
Setting binding systems that ensure the quality, effectiveness and safety of medical preparations and supplies subject to the provisions of the law and the raw materials that go into their manufacture, tracking and following them up through all stages of trading, and applying these systems to all entities participating in that process, including manufacturers, importers and distributors of these products, as well as with regard to their circulation and taking the necessary measures to withdraw the product from circulation, and these systems, as well as everything related to the follow-up system, shall be issued by a decision of the Chairman of the Board of Directors of the Authority after the approval of the Board of Directors.
Preparing and developing training programs to raise the efficiency of workers in the field of work of the authority, whether from inside or outside the authority.
Second: Executive Competencies
The Egyptian Drug Authority shall implement the laws, regulations, regulatory decisions, controls and procedures governing the registration, pricing, circulation and control of medical preparations and supplies subject to the provisions of the law and the raw materials involved in their manufacture, and follow up the application of the procedures related thereto to ensure consumer protection and take legal action before violators, and in particular may take the following:
Issuing licenses for various types of pharmaceutical establishments in a manner that does not conflict with the provisions of Law No. 127 of 1955 and the Law on Facilitating the Granting of Licenses for Industrial Establishments referred to, and the Authority is responsible for issuing technical licenses for operation only and ensuring the application of good manufacturing requirements without the rest of the licensing procedures for factories for the production of preparations, medical supplies and raw materials, in a manner that ensures rapid coordination in order to issue final licenses.
Evaluation of medical preparations and supplies subject to the provisions of the law, and pricing of medical and biological products, in accordance with the rules, standards and controls approved by the Authority's Board of Directors.
Examination and analysis of medical, biological, and veterinary preparations, herbal medicines, plant extracts, pharmaceutical preparations, cosmetics and all that falls within their equivalence in accordance with international standards and references to verify their quality, effectiveness and safety, and the conformity of medicines and pharmaceuticals and their conformity with the mandatory standard specifications approved by the Authority.
Examine and analyze medical supplies, glasses, contact lenses and electronic devices that have an impact on public health and verify their quality, effectiveness, safety, and compliance with the mandatory standard specifications approved by the Authority.
Examination and analysis of laboratory and diagnostic reagents to verify their quality, effectiveness, safety, and compliance with the mandatory standard specifications approved by the authority.
Examination and analysis of pesticides and disinfectants to verify their quality, effectiveness, safety, and compliance with the mandatory standard specifications approved by the authority.
Allowing the circulation of locally manufactured medical preparations and supplies subject to the provisions of the law and other matters that fall within the competences of the Authority, after carrying out the necessary examinations and analyzes in accordance with the procedures approved by the Authority.
Release the importer of medical preparations and supplies subject to the provisions of the law and everything related to the field of work of the Authority, after carrying out the necessary examinations and analyzes in accordance with the procedures approved by the Authority.
Establishing and updating accurate databases in the field of work of the Authority, and exchanging information with local, regional, and international bodies.
Cooperating with Egyptian and foreign universities and research centers to conduct applied research and studies in everything related to the field of work of the Authority.
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 to its work.
Implementing training programs to raise the efficiency of workers in the field of work of the Authority, and accrediting the bodies that provide training courses and qualification programs for workers in the field of the Authority's work.
Educating consumers regarding medical preparations and supplies subject to the provisions of the law and everything that falls within the competences of the Authority and coordinating with the relevant authorities and bodies.
Representing the State in regional and international bodies and organizations within the field of competence of the Authority.
Evaluate the results of the different stages of clinical trials of medical preparations and supplies 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, in accordance with the rules and procedures determined by the Authority's Board of Directors 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, it is permissible to establish reference laboratories and examination laboratories at its headquarters that include all its competencies, or to establish specialized sub-laboratories in order to achieve its objectives, and the reference laboratory may provide advisory services to government and private agencies in accordance with the rules approved by the Authority's Board of Directors.
Third: Supervisory Competencies
The Egyptian Drug Authority undertakes the following regulatory competencies:
Monitoring the application of laws, regulations, regulatory decisions, controls and procedures for practicing the activity for factories of preparations, medical supplies and raw materials subject to the provisions of the law, and everything that falls within the competence of the authority, and ensuring the application of the sound foundations of good manufacturing, whether inside or outside the Republic, and this is done through the adoption of the Egyptian Drug Authority standards and requirements of the World Health Organization for the rules and requirements of good manufacturing as a scientific reference, as well as other international standards, provided that clarifying and explanatory decisions are issued that suit the nature of And the requirements and needs of the Egyptian pharmaceutical market, in accordance with the standards and references of international regulatory bodies.
Control, follow-up, and inspection of all types of pharmaceutical establishments and their employees and take legal action against violators by applying standard specifications in production, storage or circulation, in cooperation and coordination with the relevant authorities.
Monitoring medical preparations and supplies subject to the provisions of the law and everything related to the field of work of the authority to ensure their quality, effectiveness and safety and conformity of the manufacturer's specifications to the mandatory standard specifications approved by the authority.
Control the import, export, distribution, storage and circulation of medical preparations and supplies subject to the provisions of the law.
Monitor and control the harmful effects that may result from the circulation of medical preparations and supplies subject to the provisions of the law and take measures to limit them.
Periodic follow-up and pharmacovigilance of medical preparations and supplies subject to the provisions of the law after marketing.
