Kigali, Rwanda:

I. Background

The African Medicines Agency represents a landmark achievement in Africa’s progress towards health sovereignty and self-reliance. The Treaty for the establishment of the Agency was adopted by the Assembly of the African Union in February 2019, building on the foundation laid by continental regulatory harmonisation efforts under the Pharmaceutical Manufacturing Plan for Africa. Following the entry into force of the Treaty in November 2021 and the subsequent establishment of the Agency’s governance structures, AMA has been operational since October 2025. 

Under the Treaty, the Agency’s role is to coordinate and strengthen continental regulatory systems: to provide scientific opinions on medical products of continental interest, to promote reliance and mutual recognition, to strengthen the capacity of National Regulatory Authorities (NRAs) and Regional Economic Communities (RECs), and to support the harmonisation of regulatory requirements across the continent. Regulatory decision-making on market authorisation remains a function of national authorities. This distinction between the Agency’s coordinating and scientific role and the decision-making functions of NRAs runs through the design of the 1st AMA Week. 

The Agency assumes this role at a demanding moment. The continent continues to face substandard and falsified medical products, recurrent public health emergencies, and unmet need for equitable access to quality-assured medicines, vaccines and diagnostics. At the same time, the ambition articulated in the Partnerships for African Vaccine Manufacturing framework — that Africa should manufacture 60% of the vaccines it needs by 2040 — depends on regulatory systems capable of supporting innovation, enabling market access, assuring product quality, and building confidence in locally produced products. 

The 1st AMA Week is convened to consolidate the Agency’s operational foundation: to advance the substantive work of its Technical Committees, to launch its Capacity Strengthening and Regulatory Innovation Hubs, to convene Heads of National Regulatory Authorities with WHO, and to establish a structured channel of engagement with industry.

II. Rationale

The 1st AMA Week is an event convened as a platform for AMA to showcase its work and interact with NRAs, RECs, AU institutions, partners and industry stakeholders to accelerate the implementation of the Agency’s mandate, strengthen regulatory systems, and mobilise political and technical support for access to safe, quality-assured and effective medical products. 

Four considerations shape the event. 

• The Agency’s Technical Committees are the instrument through which continental technical work is done. Their workplans, procedural documents and priority deliverables need to be settled and visible to the authorities that will rely on them. 

• Reliance, joint assessment/review and reliance depend on confidence between authorities. That confidence is built through direct engagement, which is why AMA Week includes a dedicated annual meeting of Heads of NRAs, building on the legacy of the AMRC. 

• Local manufacturing and innovation depend on predictable regulatory pathways. Industry needs a transparent, recognised channel of engagement with the Agency rather than ad hoc contact, which is the purpose of Industry Day and of the Regulatory Innovation and Manufacturing Readiness Hub. 

• Enhancing the capacity of State Parties’ NRAs and RECs to regulate medical products is one of the mandates of the Agency. Creating platforms and mechanisms for sustainable capacity building and strengthening therefore requires input from AMA stakeholders, which is why the AMA Capacity Strengthening Hub will be launched during the Week and its work will continue to be showcased in subsequent AMA Weeks as a way of incorporating inputs and consolidating the efforts of all initiatives within the continent. 

III. Program