The Egyptian Drug Authority (EDA) has unveiled its 2024 Achievements Report, highlighting major milestones that strengthened Egypt’s pharmaceutical sector and enhanced the country’s international standing. 

In December 2024, the Authority attained the World Health Organization (WHO) Maturity Level 3 (ML3) certification for medicines regulation. This achievement reflects the Egyptian government's commitment to advancing the pharmaceutical sector and strengthening national institutions through international accreditation. The certification is expected to attract new investments, reinforce confidence in Egyptian medicines,  

enhance export opportunities, and facilitate broader access to African, Arab, and Middle Eastern markets. 

The year also witnessed the issuance of the Chairman’s decision recognizing the Fifth Edition of the Egyptian Pharmacopoeia (2024), including its updates, as the official reference for the registration of pharmaceutical and biological products in the Arab Republic of Egypt. The Egyptian Pharmacopoeia serves as an authoritative scientific reference covering pharmaceutical substances and preparations, including definitions, specifications, identification tests, purity requirements, analytical methods, standardization procedures, and dosage information. 

In addition, the EDA officially launched the “Dawana” Project, a strategic initiative aimed at establishing an integrated tracking system for narcotic drugs and psychotropic substances. The project seeks to combat misuse and illicit trafficking while enhancing regulatory efficiency through accurate and continuously updated data. 

The Authority also released the Third Edition of the Egyptian Herbal Monograph (2024) and made it available on its official website. This edition contains herbal studies and clinical characteristics of medicinal plants used in Egypt and comprises 104 monographs organized into four volumes:19 traditional wild plants; 7 official wild plants; 68 cultivated medicinal plants used in herbal pharmaceutical preparations; and 

10 herbal formulations. 

Furthermore, the EDA launched the Expired Medicines Disposal Initiative, designed to ensure the safe and effective withdrawal of expired pharmaceutical products from the market. Implemented in partnership with manufacturers, distributors, and pharmacies, the initiative aims to protect consumers from potential health risks associated with expired medicines. 

Localization and Pharmaceutical Manufacturing 

During 2024, the Authority successfully localized several high-priority pharmaceutical products that had previously been unavailable in the Egyptian market. These products contribute to the treatment of conditions including:Hypercholesterolemia; Hypertension; Multiple sclerosis; Elevated intraocular pressure; Ocular congestion and infections; Glaucoma; Dry eye syndrome; Chronic obstructive pulmonary disease  

(COPD); Osteoporosis; Pediatric epilepsy; Iron overload; Hypokalemia; and Broad-spectrum bacterial infections. 

Regulatory Oversight and Inspections 

Throughout the year, the EDA conducted: 9,143 inspections of pharmaceutical manufacturing facilities; 1,807 inspections of cosmetics manufacturers; 5,086 inspections of medical device manufacturers. 

Good Manufacturing Practice (GMP) certificates issued included: 1,191 certificates for pharmaceutical facilities; 46 certificates for medical device manufacturers; 61 export-manufacturing approvals covering 14 countries. 

The Authority also rehabilitated and reactivated 48 production lines within state-owned pharmaceutical companies. 

A total of 115,000 inspections of pharmaceutical establishments were carried out, resulting in: Closure actions against 246 unlicensed premises; Execution of 2,106 enforcement campaigns; Monitoring of 580 strategic medicines and 700 products under distribution surveillance; 46,750 follow-up visits addressing medicine shortages; 

Detection of 216 cybercrimes; Closure of 70 illegal websites and online pages. 

Exports and Product Registration 

The EDA granted: 266 export approvals to 23 Egyptian companies, enabling exports to 49 countries worldwide; 8,051 registration notifications for human, veterinary, cosmetic, and herbal products; 5,575 export certificates; Inclusion of 84 pharmaceutical raw materials to support localization and investment. 

Capacity Building and Training 

The Continuing Professional Development Center delivered: 84 training programs for EDA personnel, benefiting 2,567 trainees; 112 programs for pharmaceutical and medical device industry professionals, reaching 4,189 participants. 

The Center was designated: A Regional Training Center by AUDA-NEPAD, becoming a Regional Regulatory Center of Excellence for Africa; A WHO Regional Biomanufacturing Training Centre (shortlisted) for strengthening biological manufacturing capabilities in Africa and the Eastern Mediterranean Region. 

Additionally, 17 trainees from Tanzania, Uganda, South Sudan, Burundi, Rwanda, Kenya, and Somalia received specialized training aimed at supporting vaccine manufacturing capacity. 

Public Services and Complaints Management 

The Authority handled 4,570 inquiries and complaints through the Unified Government Complaints System during 2024, successfully resolving 4,535 cases, representing an achievement rate exceeding 99.23%. 

Medical Devices and Localization 

The EDA issued: 770 registration notifications for locally manufactured and imported medical devices; 21,200 import approvals for medical devices and diagnostic reagents. 

Localized products included: Sports medicine products; External fixation systems; Steam sterilization autoclaves; Mobile X-ray systems; Surgical suction pumps; Nebulizers; Electronic tourniquet systems. 

Digital Information and Pharmacovigilance 

More than 94% of registered human pharmaceutical products now have electronic package leaflets available through the Authority’s website. 

The EDA also: Issued 441 violations related to pharmaceutical promotion and advertising; Received 488 reports concerning misleading or inappropriate promotional materials; Provided 1,230 drug information consultations to healthcare professionals and the public. 

Several awareness initiatives were launched, including: Pharmaceutical Care – Pharmacovigilance Initiative: “Together Towards Safe Medication”; “Your Medicine… Your Safety”; “An Aware Pharmacist… An Aware Society”; “Pharmaceutical Care – Minds Driven by Knowledge.” 

Laboratories and Biological Products 

Regulatory laboratories experienced significant growth: Applications evaluated through reliance pathways increased by 158% compared with 2023; Completed assessments increased by 202%; Laboratory capacity rose to 20,294 samples annually. 

he Authority also: Issued 83 registration notifications for biological products; Received 4,580 biological samples for analysis; Participated in 11 domestic and 5 international inspections; Approved six innovative product registration inquiries. 

Reference Standards Program 

A comprehensive initiative was launched to qualify domestic reference-standard manufacturers in accordance with ISO 17034:2016 requirements. Through meetings, site visits, and training activities, companies and research centers were prepared for accreditation and inclusion in the EDA’s approved white list. 

Since the establishment of the Reference Laboratories in August 2020, the number of contracted studies reached 10,189, supported by 14 technical and administrative units. 

International Cooperation 

During 2024, the EDA signed several agreements and memoranda of understanding with international partners, including: Cuba’s State Center for the Control of Medicines, Equipment and Medical Devices; Zambia Medicines Regulatory Authority (ZAMRA); Madagascar’s Ministry of Public Health; RAY Clinical Research Organization; Bilateral agreements with Tajikistan to facilitate the circulation of Egyptian pharmaceutical products. 

Egypt also secured membership on the Board of the African Medicines Agency (AMA) and launched, together with the South African Health Products Regulatory Authority (SAHPRA), the pilot phase of a joint assessment project. 

National Partnerships 

Domestically, the Authority signed: A Memorandum of Understanding with the Unified Procurement Authority to activate the pharmaceutical traceability system; A cooperation protocol with the Supreme Council of Universities to implement the mandatory internship year for pharmacy students; A joint mechanism with the National Food Safety Authority to regulate product transfers and registration according to active ingredient concentrations. 

For the infographic summarizing the Authority’s achievements, please refer to: