Corporates Kenya

Egyptian national regulatory authority reaches second highest level in WHO classification

The World Health Organization (WHO) has announced that Egypt’s National Regulatory Authority (NRA) for vaccines reached Maturity Level 3 (ML-3) – the second highest in the WHO classification of national regulatory systems. This makes Egypt’s NRA the first to reach ML-3 for vaccine regulation in the Eastern Mediterranean Region and the ninth at global level.

Reaching ML-3 offers Egyptian vaccine manufacturers the eligibility to apply for WHO pre-qualification and WHO Emergency Use Listing of their manufactured products, which will eventually allow Egypt to export COVID-19 vaccines to other countries. 

WHO classification is carried out based on its Global Benchmarking Tool to ensure vaccine quality, safety and effectiveness. Achieving Maturity Level 1 means some elements of the regulatory system exist. Maturity Level 2 indicates an evolving national regulatory system that partially performs essential regulatory functions. Maturity Level 3 confirms that a stable, well functioning and integrated regulatory system is in place. The highest level, Maturity Level 4, is achieved by a regulatory system operating at an advanced level of performance and continuous improvement.

An official benchmarking mission of the Egyptian Drug Authority – conducted by 15 international assessors during 13–17 March 2022 and using an evaluation tool cross cutting 9 functions with a set of indicators and sub-indicators – revealed that the Egyptian Drug Authority had attained ML-3.

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