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Another Step Forward for African Medicines Agency

Executive Summary

Rwanda’s health minister says the new body will play a key role in promoting cooperation and mutual recognition of regulatory decisions by individual agencies across the continent.

The creation of the African Medicines Agency drew a step nearer after the African Union signed a “host country” agreement with the government of Rwanda, which this week held a two-day conference in the capital Kigali to help speed the process up.

The agreement is “an important step in getting the work of AMA started,” said the Rwandan Food and Drugs Authority.

Rwanda was chosen as the host country for the AMA’s headquarters during a meeting of the African Union (AU) executive council in Lusaka, Zambia, in 2022. (Also see "All Eyes On Rwanda As Africa Builds Up Regulatory & Manufacturing Abilities" - Pink Sheet, 8 Aug, 2022.)

The new agency will not be a standalone regulatory body but will coordinate and promote regulatory harmonization across the different African countries and regional groupings with a view to improving access to safe, effective and quality medicines. It is also expected to play a part in building up African manufacturing capacity for medicines and vaccines.

At the signing ceremony for the host country agreement on 10 June, Rwandan health minister Sabin Nsanzimana said the AMA would play “a key role in building confidence in the quality of health products on the continent, promote cooperation and mutual recognition in regulatory decisions and facilitate the movement of health products.”

The Rwandan government has now provided the land for the construction of the agency’s HQ, and the next steps will include appointing personnel, building laboratory facilities, and so on, said Nsanzimana, who is a former head of the Rwanda Biomedical Centre.

Speaking at the second extraordinary session of the Conference of States Parties to the AMA Treaty this week, Minata Samate Cessouma, the AU’s commissioner for health, humanitarian affairs and social development, urged all countries involved to work together to achieve the goals of the AMA. “We cannot build the Africa we want without healthy Africans,” she declared.

The conference, which took place on 20-21 June, was convened by the AU Commission and the Rwandan government to “accelerate the operationalization of the AMA,” the Rwandan health ministry tweeted.

Progress With Ratification

More than 30 of the 55 AU countries have either signed or ratified the AMA Treaty. According to Health Policy Watch and the African Medicines Agency Treaty Alliance (a patient group organization), 12 countries have signed but not ratified the treaty, while 21 have ratified and deposited their instruments of ratification.

Two countries have ratified but not deposited, while 20 have neither signed nor ratified – among them major players such as South Africa and Nigeria.

Only 15 AU countries had to ratify the treaty to allow the establishment of the agency to go ahead.

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