On 31 January 2022, the Arab Republic of Egypt became the nineteenth (19th) African Union (AU) member state to deposit the instrument of ratification of the African Medicines Agency (AMA) at the AU Commission in Addis Ababa, Ethiopia. The Arab Republic of Egypt ratified the Treaty on 16 January 2022 in Cairo, Egypt.
Speaking at the occasion, Amb. Mohamed Gad, Permanent Representative of Egypt to the African Union underscored the importance of fulfilling health policies in achieving a healthy African population while re-affirming the support of the Arab Republic of Egypt in the establishment and operationalization of AMA.
H.E. Minata Samate Cessouma the Commissioner for Health, Humanitarian Affairs and Social Development at the African Union Commission emphasized the urgent need for operationalizing the AMA particularly as it will play a significant role in the fight against future pandemicsand infectiousdisease outbreaks.
Similarly, on the sidelines of the 35th Ordinary Session of the AU Assembly of the Union, the Republic of Comoros and Equatorial Guineabecame the twenty-seventh (27th) and twenty-eighth (28th) African Union (AU) member statestosign the Treaty of the African Medicines Agency (AMA) at the AU Commission on 2 February 2022,in Addis Ababa, Ethiopia.
H.E. Minata Samate Cessouma the Commissioner for Health, Humanitarian Affairs and Social Development at the African Union Commission preceded over the two signing ceremonies.
From Left: Permanent Representative of Comoros to the African Union H.E. Minata Samate Cessouma the Commissioner for Health, Humanitarian Affairs and Social Development at the African Union Commission and Mohamed Salem Boukhari Khalil, Office of the Legal Counsel
AMA will among other functions monitor the medicines market through the collection of samples in every State Party to ensure the quality of selected drugs, have them analysed and provide the results to State Parties and other interested parties, who will thus have reliable information on the quality of the drugs circulating in their countries and, where necessary, will take appropriate measures. AMA will also develop systems to monitor, evaluate and assess the comprehensiveness of national medical products regulatory systems with the view to recommending measures that will improve efficiency and effectiveness.
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 African Medicines Regulatory Harmonization (AMRH) Initiative is a stepwise approach on harmonization of requirements for registration of generic medicines while slowly expanding the scope to cover other regulatory functions such as clinical trials and ethics oversight, post-marketing surveillance including safety monitoring, and good manufacturing practice (GMP) inspections.
To date, twenty-eight (28) member states have signed the Treaty, twenty-one (21) of these have ratified and nineteen (19) have deposited the instruments of ratification to the Commission. The 15th instrument of ratification was deposited at the African Union Commission on the 5th of October 2021 and the Treaty entered into Force (as per Article 38) of the Treaty on 5th November 2021.
Here is an infographic with a status summary on the progress of signing and ratifying AMA.
The Commission expects to have the operationalization of AMA underway in 2022. 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 and of all African citizens in particular.
The Treaty is available for signature at the Headquarters of the Commission in Addis Ababa, Ethiopia.
About the African Medicines Agency (AMA)
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 enhance the the capacity of State Parties and AU recognized Regional Economic Communities (RECs) to regulate medical products to improve access to quality, safe, and efficacious medical products on the continent. 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).
