EGYPT – The World Health Organization (WHO) has issued Maturity Level Three (ML 3) status to Egypt’s National Regulatory Authority (NRA) making the Egyptian agency the first to reach ML 3 for vaccine regulation in the Eastern Mediterranean Region and the ninth at global level.
Following the formally certification by the World Health Organization, Egyptian vaccine manufacturers are eligible to apply for WHO pre-qualification and WHO Emergency Use Listing of their manufactured products which will ultimately allow Egypt to export COVID-19 vaccines to other countries.
The global public health agency states that WHO classification is carried out based on its Global Benchmarking Tool that checks regulatory functions against a set of more than 260 indicators to establish their level of maturity and functionality.
A WHO-led team of international assessors carried out the formal benchmarking mission of the Egyptian Drug Authority between February and March 2022 when they found the regulator to perform well against most indicators in the Global Benchmarking Tool.
WHO disclosed that the benchmarking activities were conducted by 15 international assessors during using an evaluation tool cross cutting 9 functions with a set of indicators and sub-indicators which revealed that the Egyptian Drug Authority had attained ML-3.
According to WHO, achieving Maturity Level 1 means some elements of the regulatory system exist while 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 and the highest level, Maturity Level 4, is achieved by a regulatory system operating at an advanced level of performance and continuous improvement, says WHO.
The WHO-Listed Authorities provide an evidence-based design for regulatory authorities to be globally recognized as meeting and applying WHO, other internationally recognized standards and guidelines as well as good regulatory practices.
The Egyptian national regulator achieves the second highest maturity level in WHO classification at a time when Egypt and five other African countries emerged as the first African recipients of mRNA technology under the global mRNA technology transfer hub initiative.
Egypt was chosen to establish its own mRNA vaccine production in ongoing efforts to bridge the gap between rich and poor countries in terms of vaccine access, bolster the continent’s ability to address health emergencies and ultimately contribute to the attainment of the universal health coverage.
The World Health Organization’s global mRNA vaccine hub was established to assist manufacturers in low- and middle-income countries in producing their own vaccines by ensuring that they have all of the necessary operating procedures and know-how to manufacture mRNA vaccines at scale and according to international standards.
At the same time, WHO continues to provide support to Egypt’s national regulatory authorities including technical support to the Egyptian Drug Authority as part of the Organization’s efforts to strengthen regulatory capacity of medical products in all of WHO’s Member States.