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"The Egyptian Drug Authority Passes International Accreditation Requirements and Obtains WHO Accreditation ""Level 3"" in the Field of Pharmaceuticals

Today, the World Health Organization (WHO) announced the accreditation of the Egyptian Drug Authority at Maturity Level 3 for regulatory authorities. This accreditation comes within the framework of the Egyptian government's support for upgrading the pharmaceutical sector and enhancing the ability of national institutions to obtain international accreditations, thereby strengthening Egypt's competitive position in the pharmaceutical industry globally.
The WHO delegation expressed its appreciation for the developments and updates witnessed by the pharmaceutical sector in Egypt recently, praising the exceptional efforts and remarkable progress made in developing the drug regulatory system thanks to the efforts of the Egyptian Drug Authority.
The organization also emphasized the pivotal roles played by the Drug Authority and state institutions in keeping pace with global developments, reflecting Egypt's commitment to applying the highest international regulatory standards.
The WHO's announcement included that the Egyptian Drug Authority's passing of international accreditation requirements and obtaining Maturity Level 3 for pharmaceuticals is an achievement that reflects the efficiency of the Egyptian regulatory system and its ability to ensure the quality and safety of medical products according to global standards. The authority has made a number of unprecedented achievements in the region to reach this accreditation in record time and with distinguished efforts not previously seen by the organization in the region.
These results confirm the international community's confidence in the Egyptian drug regulatory system, which has proven its strength and integration at the regional and international levels.
For his part, Dr. Ali Al-Ghamrawy, Chairman of the Egyptian Drug Authority, expressed his overwhelming happiness with this great achievement and dedicated this historic achievement to His Excellency President Abdel Fattah El-Sisi, President of Egypt, and to the great people of Egypt. He thanked all the employees of the Egyptian Drug Authority who worked hard and sincerely and were loyal soldiers who proved to the whole world the strength of the Egyptian drug regulatory system and its ability to develop and obtain the highest international accreditations.
The Chairman of the Egyptian Drug Authority confirmed that this accreditation will open the door for the flow of investments into the Egyptian drug market, enhance the reputation of Egyptian medicines and the high confidence in their quality and effectiveness, which will create great demand for them, enhance export opportunities, and open the door for the flow of Egyptian medical products to all parts of the African continent, the Arab world, and the Middle East region.
He pointed out that the Egyptian Drug Authority was able, in just four years, to obtain the two largest international accreditations from the WHO in the fields of vaccines and pharmaceuticals, and that with these accreditations, the Egyptian Drug Authority has become a global authority on Egyptian soil, an authority with prestige and international standing in the field of regulation and control of pharmaceuticals and vaccines, and that it will assist sister African countries wishing to benefit from the Egyptian experience.
For their part, Dr. Hety Selo, Head of the Regulation and Safety Unit, Department of Regulation and Prequalification, and Dr. Rugiero Gasper, Director General of the Department of Regulation and Accreditation at the WHO, congratulated the Egyptian Drug Authority on achieving this great achievement.
Dr. Hanan Balkhy, WHO Regional Director for the Eastern Mediterranean, said: ""This achievement reflects Egypt's firm commitment to strengthening its health system to ensure access to safe, effective, and high-quality medical products for its population. By achieving WHO Maturity Level 3 for both vaccine and medicine regulation, Egypt has set a strong example for the region and beyond. This achievement underscores the crucial role of strong regulatory systems in achieving universal health coverage and health security.""
Dr. Yukiko Nakatani, Assistant Director-General of the WHO for Access to Medicines and Health Products, said: ""Achieving WHO Maturity Level 3 for medicine regulation in Egypt, along with a previous achievement for vaccine regulation, is a recognition of the country's sustainable investment in strengthening its health system and its commitment to ensuring the application of the highest standards of safety, efficacy, and quality to medicines and other medical products. This dual recognition brings great value to the people of Egypt and sets a strong precedent for regulatory excellence in the African continent. The WHO is proud to support such progress, which underscores the vital role of strong regulatory systems in achieving universal health coverage and promoting global health equity.""
The Egyptian Drug Authority continues its leading role in enhancing Egypt's position as a leading country in drug control, contributing to the achievement of sustainable development goals and providing safe and high-quality pharmaceutical products that meet the needs of local and international markets.
This comes within the framework of the authority's keenness to benefit from global expertise and the experiences of relevant regulatory institutions, keep pace with global developments, and obtain international accreditations in the field of vaccines and medicines.
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Egyptian Drug Authority
International Accreditation Requirements and Obtains WHO Accreditation ""Level 3"" in the Field of Pharmaceuticals