{"id":105215,"date":"2024-12-22T11:42:22","date_gmt":"2024-12-22T09:42:22","guid":{"rendered":"https:\/\/www.csregypt.com\/?p=105215"},"modified":"2024-12-23T01:50:57","modified_gmt":"2024-12-22T23:50:57","slug":"egypts-achievement-of-whos-ml3-contributes-to-attaining-sdgs","status":"publish","type":"post","link":"https:\/\/csregypt.com\/en\/egypts-achievement-of-whos-ml3-contributes-to-attaining-sdgs\/","title":{"rendered":"Egypt\u2019s achievement of WHO\u2019s ML3 contributes to attaining SDGs"},"content":{"rendered":"

Egypt has achieved a significant milestone in medicines regulation, attaining maturity level 3 (ML3) in the\u00a0World Health Organization’s (WHO) global classification of national regulatory authorities<\/a>.<\/p>\n

This achievement will support Egypt\u2019s national health priorities and contribute to advancing global health and the sustainable development goals<\/p>\n

\u00a0This underscores Egypt\u2019s commitment to ensuring the availability of safe, effective, and high-quality medical products for its population.<\/p>\n

This ML3 designation follows a formal benchmarking process conducted by WHO<\/a>, marking significant progress toward strengthening the regulatory system for medical products across the African continent. Notably, this achievement builds on Egypt\u2019s earlier success in March 2022, when it reached ML3 for vaccines regulation (locally produced and imported). \u00a0With this latest recognition, Egypt becomes the first country in Africa to achieve ML3 for both medicines and vaccines regulation, as assessed by WHO\u2019s\u00a0Global Benchmarking Tool<\/a>\u00a0(GBT).<\/p>\n

The WHO benchmarking process, conducted using its GBT, evaluates regulatory systems against more than 250 indicators. Maturity level 4, the highest level, represents an advanced regulatory system committed to continuous improvement. Maturity level 3 reflects a stable, well-functioning, and integrated regulatory system.<\/p>\n

The Egyptian Drug Authority (EDA) attained ML3 for medicines regulation following a rigorous benchmarking process finalized in November 2024, achieved through close collaboration with WHO regional office for the Eastern Mediterranean Region and coordination by WHO country office in Egypt.<\/p>\n

\u201cThis milestone reflects Egypt\u2019s firm commitment to strengthening its health system to ensuring access to safe, effective, and high-quality medical products for its population,\u201d said Dr Hanan Balkhy, WHO Regional Director for the Eastern Mediterranean Region. \u201cBy achieving WHO maturity level 3 for both vaccines and medicines regulation, Egypt has set a powerful example for the region and beyond. This accomplishment underscores the critical role of strong regulatory systems in achieving universal health coverage and health security.\u201d<\/p>\n

The WHO global benchmarking process is a key component of its\u00a0programme to strengthen regulatory systems<\/a>\u00a0worldwide. It evaluates core functions such as product authorization, market surveillance and adverse event detection. Regulatory authorities that reach ML3 and ML4 may qualify as WHO-listed Authorities, subject to additional performance assessments.<\/p>\n

\u201cThe attainment of WHO maturity level 3 for medicines regulation in Egypt, coupled with a previous milestone for vaccines regulation, is a recognition of the country\u2019s sustained investment towards strengthening its health system and its commitment to ensuring that the highest standards of safety, efficacy and quality are applied to medicines and other medical products,\u201d said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. \u201cSuch dual recognition brings significant value to the people of Egypt and establishes a solid precedent for regulatory excellence on the African continent. WHO is proud to support such progress which underscores the vital role of strong regulatory systems in achieving universal health coverage and advancing global health equity.”<\/p>\n

Effective regulation of medical products is essential for any well-functioning healthcare system, ensuring access to quality, safe, and effective medicines, vaccines, and other health products. Strong regulatory authorities play a critical role by performing functions such as rapid product authorization and robust safety monitoring, ultimately leading to better health outcomes.<\/p>\n

\n","protected":false},"excerpt":{"rendered":"

Egypt has achieved a significant milestone in medicines regulation, attaining maturity level 3 (ML3) in the\u00a0World Health Organization’s (WHO) global classification of national regulatory authorities. This achievement will support Egypt\u2019s national health priorities and contribute to advancing global health and the sustainable development goals \u00a0This underscores Egypt\u2019s commitment to ensuring the availability of safe, effective, […]<\/p>\n","protected":false},"author":410,"featured_media":105218,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[984,13332],"tags":[6463,16784,16783,6984,16172],"yoast_head":"\nEgypt\u2019s achievement of WHO\u2019s ML3 contributes to attaining SDGs - Csr Egypt<\/title>\n<meta name=\"description\" content=\"Egypt has achieved a significant milestone in medicines regulation, attaining maturity level 3 (ML3) in the\u00a0World Health Organization's (WHO) global classification of national regulatory authorities.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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