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Egypt reaches WHO ML3 in medicines regulation

This makes Egypt the first African country to achieve this classification in the field of regulating medicines and vaccines.
29.12.24 | Source: Egyptian Gazette

Africa Centres for Disease Control and Prevention (Africa CDC) congratulated the Egyptian Drug Authority (EDA) for its achievement in obtaining the World Health Organisation’s Maturity Level 3 in medicines regulation (ML3).


This makes Egypt the first African country to achieve this classification in the field of regulating medicines and vaccines.


Africa CDC stressed that this outstanding achievement highlights Egypt’s leadership in promoting organisational excellence and health security.


Director-General of Africa CDC, Dr Jean Kaseya, praised the Egyptian government and EDA, saying that Egypt’s achievement was a source of great pride—not only for the country but for the entire continent. It represents an important step towards achieving the African Union’s Agenda 2063 and promoting health justice.


Kaseya stressed that Egypt’s progress in achieving an ML3 classification of drugs and vaccines strongly demonstrates what can be achieved through integrated governance and that the Africa CDC will continue to work closely with WHO and the African Medicines Agency (AMA).





The report noted that WHO’s global measurement tool evaluates the performance of national regulatory systems based on more than 250 indicators, and with their ML3 rating, Egypt is well positioned to make further progress, making it a role model for other African countries.




The Egyptian drug industry is an example of domestic production for health security, producing more than 90 percent of its medicines locally and exporting them to more than 100 countries.


Africa CDC reaffirms its commitment to working with AMA and that Egypt’s success is evidence of the strength of co-operation, capacity building, and adherence to international standards.


Africa CDC is an African Union public health agency that is independent and supports member states in strengthening their health systems and helps improve disease surveillance, emergency response, and disease control.

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