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.