The Republic of Sierra Leone becomes the eighth (8th) Member State to deposit the instrument of ratification of the African Medicines Agency (AMA). The Republic of Sierra Leone ratified the Treaty for the establishment of AMA on 28 May 2021 in Free Town, Sierra Leone and deposited the instrument of accession, to the Commission of the African Union (AU) on 14 June 2021 in Addis Ababa, Ethiopia. The Office of the Legal Counsel of the African Union Commission received the instrument from Sierra Leone.
The ratification and deposit of the instrument follows a high-level engagement between H.E. President Julius Maada Bio of the Republic of Sierra Leone and Honourable Michel Sidibé the African Union Special Envoy for the AMA on May 10, 2021 in Free Town, Sierra Leone.
AMA will be the second specialized continental health agency after the Africa Centres for Disease Control and Prevention (Africa CDC) that will enhance capacity of State Parties and AU recognized Regional Economic Communities (RECs), to regulate medical products in order to improve access to quality, safe and efficacious medical products on the continent.
The efforts to coordinate the regulatory systems strengthening and harmonization initiative under the leadership of the African Medicines agency will provide improved sovereign control and regulation of medical products that will allow African Union Member States to provide for efficient and effective protection of public health against risks associated with the use of substandard and falsified medical products. AMA will facilitate expeditious approval of products that address the health needs of the African populace, especially for diseases that disproportionately affect Africa.
In the face of a looming pandemic, the necessity of AMA has been amplified and particularly its function in coordinating joint reviews of applications for the conducting of clinical trials and providing technical support in quality control of drugs at the request of Member States which do not have the structures to carry out these examinations/controls/checks.
AMA will provide regulatory guidance, scientific opinions and common framework for the regulatory actions on medical products, as well as priority and emerging issues and pandemics in the event of a public health emergency on the continent with cross border or regional implications where new medical products are to be deployed for investigations and clinical trials.
AMA will also 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 (RECs) and Regional Health Organizations (RHOs).
In addition, AMA will examine, discuss and/or express regulatory guidance on any regulatory matter within its mandate, either on its own initiative or at the request of the African Union Regional Economic Communities (RECs), or State Parties. It will also provide guidance on regulation of traditional medical products.
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 once ratified by fifteen African Union Member States.
More information about AMA Treaty @ https://au.int/en/treaties/treaty-establishment-african-medicines-agency
For further media inquiries, please contact:
• Office of the Legal Counsel of the African Union Commission
• Dr. Margaret Agama-Anyetei, Head of Division for Health, Nutrition and Population; Health, Humanitarian Affairs & Social Development (HHS); AU Commission; Tel: +251115162211; E-mail: Agama-AnyeteiM@africa-union.org
For further media inquiries, please contact:
1. Mrs. Esther Azaa Tankou | Head of Information Division | Information and Communication Directorate, African Union Commission | Mobile: +251911361185 | E-mail: yamboue@africa-union.org
2. Ms. Dorothy Njagi | Strategic Communication Expert, Division for Health, Nutrition and Population | Health, Humanitarian Affairs & Social Development (HHS), African Union Commission | Mobile: +251940559950 | E-mail: njagid@africa-union.org
3. Mr. Gamal Eldin Ahmed A. Karrar | Senior Communication Officer | of Information and Communication Directorate | E-mail: GamalK@africa-union.org
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