The People’s Democratic Republic of Algeria becomes the ninth (9th) Member State to deposit the instrument of ratification of the African Medicines Agency (AMA). The Republic of Algeria ratified the Treaty for the establishment of AMA on 10 June 2021 and deposited the instrument of accession, to the Commission of the African Union (AU) on 22 June 2021 in Addis Ababa, Ethiopia. H.E. Amira Elfadil Mohamed, Commissioner for Health, Humanitarian Affairs and Social Development, at the African Union Commission, received the instrument from H.E. Salah Francis Elhamdi Ambassador of Algeria to the Federal Republic of Ethiopia and the African Union.
Speaking during the official deposit of the instrument H.E. Amira Elfadil Mohamed noted that the need for Africa to produce its medicines and vaccines has been amplified by the COVID-19 pandemic and without a regulatory body this cannot be achieved. “AMA as a regulatory body will harmonize the policies as well as strengthen the capacity for Member States to produce medicines and medical products,” she noted.
The ratification and deposit of the instrument follow a high-level engagement between H.E Abdelmadjid Tebboune President of the Republic of Algeria and Honourable Michel Sidibé the African Union Special Envoy for the AMA on June 11, 2021 in Algiers, Algeria.
AMA will be the second specialized continental health agency after the Africa Centres for Disease Control and Prevention (Africa CDC) that will be established out of the desire to use continental institutional, scientific and regulatory resources to improve access to safe, efficacious and quality medicines. AMA shall build into the efforts of the established African Medicines Regulatory Harmonization (AMRH) in 2009, under the management and guidance of the New Partnership for Africa’s Development (AUDA-NEPAD) working with Regional Economic Communities (RECs) and Regional Health Organizations (RHOs), to facilitate harmonization of regulatory requirements and practice among the national medicines regulatory authorities (NMRAs) of the AU Member States. This 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. AMA functions as outlined in the Treaty shall include, but not limited, to 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). AMA will also provide advice on the marketing authorization application process for the priority drugs described by the State Parties or on the products proposed by the pharmaceutical laboratories.
The 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.
More information about AMA Treaty @ https://au.int/en/treaties/treaty-establishment-african-medicines-agency
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