The Arab Republic of Egypt becomes the twenty first (21st) African Union (AU) Member State to sign the Treaty for the establishment of the African Medicines Agency (AMA) on 27 July 2021, at the AU Commission in Addis Ababa, Ethiopia. H.E. Amira Elfadil Mohamed, Commissioner for Health, Humanitarian Affairs and Social Development, at the African Union Commission, received the delegation from the Arab Republic of Egypt.

H.E. Amira Elfadil Mohamed underscored that AMA shall be instrumental in ensuring the continent has not only a strong medicines regulatory agency but also it shall promote local manufacturing of pharmaceutical products on the continent. She encouraged Egypt to move to the next step of ratifying the Treaty for the establishment of AMA.

H.E. Osama Abdel Khalik, Permanent Representative of Egypt to the African Union who was leading the delegation from Egypt made reference to the Egyptian capacities in the field of manufacturing medicines and indicated that Egypt will intensify the efforts to accelerate the process of ratifying the treaty.

The signing of the Treaty follows a high-level engagement between H.E. Amb Soha ElGindy Assistant Minister of Foreign Affairs for the African organizations and communities at the Ministry of Foreign affairs of the Arab Republic of Egypt and H.E. Dr. Hala Zaid Minister of Health and population of the Arab Republic of Egypt with Honourable Michel Sidibé the African Union Special Envoy for the AMA and Dr. Margaret Agama-Anyetei, Acting Director for Health and Humanitarian Affairs Directorate at the African Union Commission. On July 12 and 13, 2021 in Cairo, Egypt.

The signing of the The Arab Republic of Egypt demonstrates the desire by Member States to avert the existence of substandard and falsified medical products that pose a risk to public health, harms patients and undermines confidence in healthcare delivery systems.

The AMA Treaty was adopted by Heads of States and Government during their 32nd Ordinary Session of the Assembly on 11 February 2019 in Addis Ababa, Ethiopia. The African Medicines Agency aspires to provide support for the improvement of weak regulatory systems. AMA shall build on the efforts of the African Medicines Regulatory Harmonization (AMRH) initiative (2009), which is led by the Africa Union Development Agency - the New Partnership for Africa's Development (AUDA-NEPAD). The AMRH initiative provides guidance to AU recognized Regional Economic Communities (RECs) and Regional Health Organizations (RHOs), to facilitate harmonization of regulatory requirements and practice among the national medicines authorities (NMRAs) of the AU Member States.

AMA will be the second specialized health agency of the African Union after the Africa Centres for Disease Control and Prevention (Africa CDC). The agency will among other functions coordinate and strengthen ongoing initiatives to harmonize medical products regulation and enhance the competence of Good manufacturing practices (GMP) inspectors to do so. AMA will also coordinate the collection, management, storage and sharing of information on all medical products including substandard and falsified medical products, with all its State Parties and globally.

The agency will also designate, promote, strengthen, coordinate and monitor Regional Centres of Regulatory Excellence (RCOREs) with a view to developing the capacity of medical products regulatory professionals. AMA will additionally promote the adoption and harmonization of medical products regulatory policies and standards, as well as scientific guidelines, and coordinate existing regulatory harmonization efforts in the Regional Economic Communities and Regional Health Organizations.

Fifteen (15) ratifications have been reached. However, AMA Treaty will enter in to force 30 days upon the deposit of the 15th instrument of ratification at the Commission. The African Union Commission encourages all its Member States to sign and ratify the Treaty for the establishment of AMA in the interest of public health, safety and security. The Treaty is available for signature at the Headquarters of the Commission in Addis Ababa, Ethiopia.

Further information should be directed to:

1. Office of the Legal Counsel of the African Union Commission

2. Dr. Margaret Agama-Anyetei, Ag. Director of Health and Humanitarian Affairs Directorate; Department of Health, Humanitarian Affairs and Social Development, AU Commission; Tel: +251115182211; E-mail: Agama-AnyeteiM@africa-union.org

For further media inquiries, please contact:

1. Ms. Dorothy Njagi | Strategic Communication Expert | Directorate of Health and Humanitarian Affairs | Department of Health | Humanitarian Affairs and Social Development | African Union Commission | Mobile: +251940559950 | E-mail: njagid@africa-union.org