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The African Union Commission receives the target instrument of ratification for the establishment of the African Medicines Agency (AMA)

The African Union Commission receives the target instrument of ratification for the establishment of the African Medicines Agency (AMA)

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October 05, 2021

On 5 October 2021, the Republic of Cameroon became the fifteenth (15th) member state to deposit the instrument of ratification of the African Medicines Agency (AMA). The deposit of the 15th instrument of ratification marked the beginning of the thirty-day countdown, for the Treaty to enter into Force (as per Article 38) of the Treaty signifying the establishment of the African Medicines Agency (AMA). The Republic of Cameroon ratified the Treaty on 7 September 2021 in Yaoundé, Cameroon.

H.E. Amira Elfadil Mohammed, Commissioner for Health, Humanitarian Affairs and Social Development, at the AU Commission received the instrument from H.E. Churchill Ewumbue-Munono Ambassador of Cameroon to Ethiopia and the African Union. The Commissioner expressed her delight on having AMA come into force before the end of 2021 adding that Africa needs this Agency to be operational urgently. “AMA will complement the work of the Africa Centres for Disease Control and Prevention (Africa CDC) in bridging the gap in regulatory systems strengthening of medical products in the protection of African population against risks associated with the use of substandard and falsified medical products and technologies,” the Commissioner said.

Speaking at the occasion, Ambassador Ewumbue-Munono expressed the political commitment from the government of Cameroon in the establishment of AMA.

The past few months has seen increased momentum to sign and ratify the AMA Treaty intensify particularly among member states that had signed the Treaty. The COVID-19 pandemic has been a contributing factor to the sense of urgency and the need for strengthened, improved and harmonised regulation of medicines, medical products and technologies across the continent. In addition, the high-level advocacy activities by the African Union Special Envoy for the African Medicines Agency (AMA), Honourable Michel Sidibé, with the support of the Commission further accelerated the rate of ratification.

AMA aims to provide support for weak regulatory systems. It will among other functions promote the adoption and harmonization of medical products regulatory policies and standards, as well as scientific guidelines, and coordinate existing regulatory harmonization efforts across the continent.

To date, eighteen (18) member states have ratified the AMA Treaty and fifteen (15) of these have deposited the instruments of ratification to the Commission. In the build-up to the operationalization of the AMA, the Commission has invited member states to submit proposals for the hosting of the Africa Medicines Agency Headquarters. The Commission has also further extended the deadline for submission of interest to host the AMA up to 15th October 2021, as per the ruling of the Permanent Representatives Committee (PRC) on 6th September 2021.

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.

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 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. 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).

Further information should be directed to:

1. Mohamed Salem Boukhari Khalil, Office of the Legal Counsel of the African Union Commission Tel: +251911405697; Email: KhalilM@africa-union.org

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

2. Mr. Gamal Eldin Ahmed A. Karrar | Senior Communication Officer | Information and Communications Directorate | E-mail: GamalK@africa-union.org

Information and Communication Directorate, African Union Commission I E-mail: DIC@africa-union.org
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