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Regulators Seek Ratification of Continental Medicine Agency

by Daniel Sabiiti
1:54 pm

Participants after deliberation

The 9th African medicines regulators conference has opened in Kigali with a new drive to push African countries to ratify the African Medicines Agency (AMA)Treaty for the Establishment of the continental regulator.

The two-day conference that opened this August 23, 2023 showed that only 26 countries have so far ratified the agreement as the rest struggle with legal structures despite the urgency of establishing the agency.

Establishment of the AMA is a drive to attain the AU health goals 2030, reduce dependency on imported manufactured medicines, curb counterfeits and ultimately enhance the African Continental Free Trade Area agreement (AfCFTA).

So far, The African Medicines Regulators Conference (AMRC) convenes 55 National Regulatory Authorities (NRAs) across the continent to share knowledge and best practices on regulatory matters.

The AMRC has so far played an essential role in facilitating harmonization across the continent through the African Medicines Regulatory Harmonization (AMRH) initiative which was rolled out in five Regional Economic Communities (RECs).

The AMRH initiative has provided a solid foundation for the establishment of the African Medicines Agency (AMA)- which will build on regional harmonization initiatives to strengthen regulatory systems continent-wide and facilitate regulatory reliance in alignment with internationally acceptable standards.

Dr. Boitumelo Semete-Makotlela, the Chair of the AMRH Steering Committee said the AMRH initiative has been providing technical support to operationalize the AMA since the Treaty came into force on 5 November 2021.

As part of providing technical support, the AMRH has strengthened continental Technical Committees (TCs) that are developing guidance documents and processes for the consideration of the AMA Governance structures.

While the establishment of AMA will enable local citizens to have quality medical products under the AfCFTA, officials said that there is more work to be done at national levels.

“It is nine years now and we have a long way to go but five countries have reached the maturity level of producing African medicines. The establishment of AMA is a credit to our work but we also need to put more effort to have more than 26 countries ratify the AMA treaty,” said Dr. Ahamada Said Fazul, the Chairperson of the AMRC Assembly and Head of NRA, Comoros.

New Models Announced

To ensure the scientific and capacity aspects, AUDA- NEPA announced newly designated Regional Centres Of Regulatory Excellence (RCOREs) on vaccines regulatory oversight in four countries (South Africa, Tanzania, Ghana and Egypt) to mentor other countries in capacity building and operational research to pilot-test innovations and interventions and best practices for scale up to other NMRAs.

AUDA-NEPAD said that by the end of next year 2024 the AMA is expected to be in place after establishing the legal, administrative and regulatory entities that will guide the agency.

Principal Programme Officer – Policy Specialist AUDA- NEPAD, Chimwemwe Chamdimba said the way forward is to start continental joint progress assessment, engage the current technical committees to start operationalizing the establishment of the AMA and by 2024 there will be an African Medicine regulatory college which will build capacity but learning from existing agencies (European Medicines Agency).

Rwanda is currently the proposed home of the African Medicines Agency with offices in Kigali. The AU signing of host agreement was signed in June.

Emile Bienvenu, the Director General of Rwanda FDA said that Rwanda will benefit from the AMA establishment especially with its current partnership and established infrastructure and expertise to start manufacturing key vaccines.

World Health Organisation and the Africa Centers for Disease Control and Prevention (CDC) officials at the conference promised to support the AMA agenda with financial and technical support to improve health services on the continent.

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