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  • Ahmed Saleh

Saudi SFDA reaches WHO ML4 for medicine and vaccine regulation

Riyadh, October 30, 2023, In a recent announcement, the World Health Organization (WHO) revealed that Saudi Arabia, through the Saudi Food and Drug Authority (SFDA), has attained maturity level four (ML4) in the regulation of medicines and vaccines. This prestigious achievement, signifying the highest level in the WHO's classification for regulatory authorities, underscores SFDA's commitment to stringent requirements aimed at safeguarding drug safety and advancing public health.

Dr. Yukiko Nakatani, the Assistant Director-General for Access to Medicines and Health Products at the WHO, hailed this accomplishment as a significant milestone not only for the Kingdom of Saudi Arabia but also for the entire region. She highlighted that SFDA has made history by becoming the first national regulatory authority in the Eastern Mediterranean and the third globally to attain ML4, as determined by the WHO's benchmarking exercise.

Nakatani emphasized the enduring partnership between the WHO and the Saudi government, working in unison to achieve the objectives of comprehensive universal health coverage and sustainable development. Attaining ML4 status not only reinforces this collaborative effort but also ensures improved access to high-quality, safe, and effective medical products. Furthermore, it facilitates the global market entry of locally manufactured medications, promoting health and well-being on a broader scale.

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