On 22 June 2021, The People’s Democratic Republic of Algeria deposited the instrument of ratification of the African Medicines Agency (AMA), becoming the 9th African Union Member State to ratify the Treaty.
H.E. Salah Francis Elhamdi Ambassador of Algeria to the Federal Republic of Ethiopia and the A, presented the ratification instrument to the AUC Commissioner for Health, Humanitarian Affairs and Social Development, H.E. Amira Elfadil Mohamed at the AU Headquarters in Addis Ababa, Ethiopia.
The AMA will be the second specialized continental health agency after the Africa Centres for Disease Control and Prevention (Africa CDC). The establishment of the AMA is derived from the desire to use continental institutional, scientific and regulatory resources to improve access to safe, efficacious and quality medicines.
The AMA shall build into the efforts of the established African Medicines Regulatory Harmonization (AMRH), under the management and guidance of the African Union Development Agency (AUDA-NEPAD) working with Regional Economic Communities (RECs) and Regional Health Organizations, to facilitate harmonisation of regulatory requirements and practice among the national medicines regulatory authorities of the AU Member States. This aim is to meet internationally acceptable standards, and provide a favourable regulatory environment for pharmaceutical research and development, local production and trade across countries on the African continent. The AMA’s functions include amongst others, the evaluation and decision on selected medical products, including complex molecules, for treatment of priority diseases/conditions, as determined by the African Union and World Health Organization (WHO).
The AMA will also provide advice on the marketing authorisation application process for the priority drugs described by the State Parties or on the products proposed by the pharmaceutical laboratories. The AU 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.
The African Medicines Agency will enter into force thirty days after the deposit of the fifteenth instrument of ratification of the AMA Treaty to the Commission.
Learn more about AMA Treaty at https://au.int/en/treaties/treaty-establishment-african-medicines-agency
