The Egyptian Drug Authority (EDA) has attained Maturity Degree 3 (ML3) for each medicines and vaccines regulation on Saturday 20 December.
This achievement makes Egypt the primary nation in Africa to attain ML3 for each classes. The Maturity stage 3 displays a secure, well-functioning, and built-in regulatory well being system.
This newest recognition builds upon Egypt’s earlier success in March 2022, when it first achieved ML3 for vaccine regulation.
The WHO’s World Benchmarking Software (GBT) evaluates nationwide regulatory authorities towards over 250 indicators, assessing key features reminiscent of product authorization, market surveillance, and antagonistic occasion detection.
Attaining ML3 signifies a secure and well-functioning regulatory system, important for guaranteeing entry to secure and efficient medical merchandise.
Hanan Balkhy, WHO Regional Director for the Jap Mediterranean Area, highlighted to Ahram On-line that this accomplishment underscores Egypt’s dedication to strengthening its well being system.
“By attaining WHO maturity stage 3 for vaccines and medicines regulation, Egypt has set a robust instance for the area and past,” she said.
The EDA’s success stemmed from a rigorous benchmarking course of that concerned shut collaboration with the WHO’s regional and nation places of work.
This analysis utilized the WHO’s GBT to evaluate the EDA’s regulatory techniques towards over 250 indicators, specializing in important features reminiscent of product authorization and market surveillance.
The method, accomplished in November 2024, confirmed the EDA’s adherence to excessive worldwide requirements, ensuing within the attainment of Maturity Degree 3 (ML3) for each medicines and vaccine regulation.
Yukiko Nakatani, WHO Assistant Director-Normal for Entry to Medicines and Well being Merchandise, famous that this achievement acknowledges Egypt’s sustained funding in its well being system and its dedication to sustaining excessive security and high quality requirements for medicines.
Because the EDA Chairman, Ali El-Ghamrawy, pointed out that these twin accreditations are anticipated to draw overseas funding into the Egyptian pharmaceutical market and improve the worldwide status of Egyptian medicines.
He expressed optimism that this recognition would result in elevated demand for Egyptian prescription drugs throughout Africa and the Arab world.
