WHO - World Health Organization Regional Office for Eastern Mediterranean

10/01/2025 | Press release | Distributed by Public on 10/01/2025 06:32

Saudi FDA and OIC organize workshop on strengthening regulatory systems in collaboration with WHO

1 October 2025, Riyadh, Saudi Arabia--The Saudi Food and Drug Authority (SFDA), through its educational arm, the SFDA Academy, and the Organization of Islamic Cooperation (OIC), organized a virtual workshop in collaboration with the World Health Organization (WHO). The initiative was aligned with the "Riyadh Declaration" issued during the 3rd Meeting of the Heads of National Medicines Regulatory Authorities (NMRAs) in OIC member states, which emphasized enhancing cooperation and developing regulatory capacities.

The workshop, attended by 200 specialists from 57 OIC member states, was held under the title: "Strengthening Regulatory Systems: The Saudi FDA's Path to ML4 Compliance with WHO's Global Benchmarking Tool (GBT) - Achievements and Lessons Learned" which is based on a unified international standard for assessing national regulatory systems for medicines and vaccines.

During the workshop, the SFDA shared its experience in advancing regulatory systems to ensure timely access to high-quality medicines and to address the challenges posed by substandard and falsified products. Notably, Saudi Arabia achieved the highest level of the WHO Global Benchmarking Tool (GBT), Maturity Level 4 (ML4)-making it the first country in the region and the third globally to obtain this classification. This milestone qualifies the Authority to serve as a reference body for decisions related to the approval of medical products.

The workshop also included an overview of the GBT framework and maturity levels, highlighted international experiences, and featured an open discussion where participants exchanged insights, shared practical solutions, and explored opportunities for technical collaboration.

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