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Saudi Arabia Achieves WHO’s Top Regulatory Maturity Level

The Saudi Food and Drug Authority, the National Regulatory Authority of Saudi Arabia, has been classified by the World Health Organisation (WHO) as a regulatory authority for medical products at the highest level, known as maturity level four (ML4), based on the Global Benchmarking Tool (GBT). This means that SFDA is constantly improving its operations and performing at an advanced level.

In order to ensure that everyone has access to high-quality medications, vaccinations, and other health supplies, medical product regulation is crucial for all health systems. Regulatory bodies that operate effectively not only guarantee the effectiveness, safety, and quality of medical items but also carry out vital tasks, including prompt medical product authorization and safety patrols.

All medical product regulations are under the exclusive jurisdiction of the SFDA, which was founded in 2003. A WHO-led group of international regulators from five WHO regions, working closely with the WHO Regional Office for the Eastern Mediterranean, officially benchmarked SFDA for medications and vaccines in November 2022. By closely collaborating with WHO to put its team of worldwide regulatory experts’ recommendations into practice, SFDA has attained ML4.  

Global Benchmarking instrument, an assessment instrument that compares regulatory functions to over 260 indicators, serves as the foundation for WHO’s evaluation of regulatory bodies. The metrics comprise an assessment of fundamental regulatory duties, including product approval, product testing, market monitoring, and the capacity to identify and address negative consequences in order to determine the benchmarked regulatory authority’s degree of development and usefulness.

The first in the Eastern Mediterranean and the third globally to reach ML4 based on a WHO benchmarking exercise, SFDA’s accomplishment is a major turning point for Saudi Arabia and the region, according to Assistant Director-General for Access to Medicines and Health Products Dr. Yukiko Nakatani. By assuring and improving access to high-quality, secure, and efficacious medical products, this accomplishment underscores the long-standing partnership between the World Health Organisation and the Government of Saudi Arabia towards the goals of universal health coverage and sustainable development.

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Quality and safety standards must be applied before resilient health systems in any context may be debated, planned, or put into action. With the lengthy history of cooperation between Saudi Arabia and the WHO, the recent success of SFDA represents a critical turning point toward the provision of high-quality healthcare. In the WHO’s hierarchy of regulating bodies for medical items, this is the highest level. We eagerly anticipate new efforts to guarantee that everyone has access to high-quality healthcare, said Dr. Ahmed Al-Mandhari. 

As of March 2022, countries that possess ML3 and ML4 have the opportunity to apply to become WHO-listed authorities (WLAs). This program identifies regulatory bodies that other regulatory bodies and the WHO may use as a point of reference when making decisions about the approval of medical products.

While Saudi Arabia has achieved the top regulatory maturity level in terms of healthcare regulations, it is still important for healthcare organizations to ensure that they have qualified and competent healthcare professionals working within their facilities. 

We at Dynamic Health Staff can help healthcare organizations in Saudi Arabia recruit high-quality healthcare professionals, including nurses, to ensure that patients receive the best possible care. As a recruitment agency, we offer comprehensive support for internationally trained nurses seeking to work in Saudi Arabia, including assistance with the application process, language requirements, and relocation. 

With our help, healthcare organizations in Saudi Arabia can build a strong team of healthcare professionals to deliver quality care to patients. For additional information, please email enquiry@dynamichealthstaff.com or call +919810017608. Get up-to-date job information, news, and trends by subscribing to our newsletter. Click here to contact Dynamic Health Staff today! 

 

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