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Saudi Arabia regulatory system becomes third to reach WHO Maturity Level 4

Ahmed Alghamdi/Saudi FDA
Ahmed Alghamdi/Saudi FDA

The World Health Organization (WHO) announces that the Saudi Food and Drug Authority (SFDA), the National Regulatory Authority (NRA) of Saudi Arabia has achieved maturity level four (ML4) for medicines and vaccines regulation, the highest level in WHO’s classification of regulatory authorities for medical products according to the Global Benchmarking Tool (GBT) signifying that SFDA is operating at an advanced level of performance with continuous improvement. 

Regulation of medical products is extremely important for all health systems and for access to quality vaccines, medicines and other health products. In addition to ensuring the quality, safety and efficacy of medical products, regulatory authorities that function well also perform critical activities such as timely authorization of medical products and safety monitoring.

SFDA was established in 2003 as the sole agency responsible for regulatory oversight of all medical products. In November 2022, SFDA was formally benchmarked for medicines and vaccines by a WHO-led team of international regulators drawn from five WHO regions and in close collaboration with the WHO Regional Office for the Eastern Mediterranean. SFDA has achieved ML4, working closely with WHO to implement the recommendations made by its team of international regulatory experts.   

WHO’s assessment of regulatory authorities is based on the Global Benchmarking Tool – an evaluation tool that checks regulatory functions against a set of more than 260 indicators. The indicators include a review of core regulatory functions such as product authorization, testing of products, market surveillance, and the ability to detect and respond to adverse effects to establish the level of maturity and functionality of the benchmarked regulatory authority.

This achievement by SFDA represents a significant milestone for Saudi Arabia and the region as SFDA becomes the first in the Eastern Mediterranean and the third one worldwide to reach ML4 based on WHO benchmarking exercise,” said Dr Yukiko Nakatani, Assistant Director-General for Access to Medicines and Health Products. ‘This achievement reaffirms the long-standing collaboration between the WHO and the Government of Saudi Arabia towards the targets of universal health coverage and sustainable development goals, by ensuring and enhancing access to quality assured, safe, and effective medical products’.

“Resilient health systems in every setting cannot be discussed, planned, or implemented without applying quality and safety measures. Saudi Arabia and the WHO have a long history of collaboration, and this recent achievement by SFDA is a significant milestone on the road to achieving quality healthcare. This is the highest level in WHO’s classification of regulatory authorities for medical products. We look forward to further initiatives to ensure quality healthcare services for everyone. Working together to achieve universal health coverage and health for all by all.” Dr Ahmed Al-Mandhari, WHO Regional Director

Countries with ML3 and ML4 are eligible to become a WHO-listed authority (WLA), a scheme operational since March 2022, which designates regulatory authorities that may be considered as a reference point by WHO and other regulatory authorities for reaching their own decisions in approving medical products.

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