DR. DELESE MIMI DARKO, DIRECTOR-GENERAL OF THE AFRICAN MEDICINES AGENCY,
DR. YOSSOUNON CHABI, CHAIRPERSON OF THE AFRICAN MEDICINES AGENCY GOVERNING BOARD,
HONOURABLE MEMBERS OF THE GOVERNING BOARD,
PROF. EMILE BIENVENU, DIRECTOR-GENERAL, RWANDA FOOD AND DRUGS AUTHORITY,
HEADS OF NATIONAL REGULATORY AUTHORITIES,
REGIONAL ECONOMIC COMMUNITY COORDINATORS,
DISTINGUISHED PARTNERS,
LADIES AND GENTLEMEN,

It is a great honour for me to address you at this Maiden Forum of Heads of National Regulatory Authorities and Regional Economic Community Coordinators, convened under the timely and forward-looking theme: “Building the African Medicines Agency Together.”

On behalf of the African Union Commission, I wish to express our sincere appreciation to the Government of the Republic of Rwanda for hosting this important gathering, and to commend DG Mimi and her hardworking Team for bringing together, for the first time, the leadership of Africa’s medicines regulatory ecosystem on a single continental platform.

I also extend my appreciation to all of you for your presence, your leadership and your sustained commitment to strengthening medicines regulation in Africa. This gathering is not merely procedural or symbolic, it represents a defining moment in Africa’s collective journey toward health sovereignty, regulatory excellence and continental integration.

A Strategic Turning Point for Africa

This Forum marks a critical turning point in Africa’s efforts to build stronger, more coherent and more effective regulatory systems for medical products. It reflects our shared recognition that fragmented regulatory frameworks, uneven capacities and prolonged timelines for access to quality-assured medicines are no longer acceptable for our continent.

Today, we meet not only as regulators or institutions, but as co-architects of Africa’s future health security.

This Forum is historic precisely because it brings together, in a structured and deliberate manner, the custodians of national regulatory authority and the coordinators of regional integration, united by a common continental vision.

The African Medicines Agency: Purpose and Promise

The establishment of the African Medicines Agency (AMA) was never intended to replace or diminish national or regional authorities. On the contrary, AMA was conceived as a platform for coherence, convergence and collective strength, one that amplifies national capacity, aligns regional efforts and positions Africa as a credible global regulatory actor.

AMA is anchored in our shared commitment to:

• Protect public health,
• Strengthen health security, and
• Advance Africa’s development priorities,

In line with Agenda 2063, the Pharmaceutical Manufacturing Plan for Africa (PMPA) and the broader continental health agenda.

This Forum, therefore, represents the transition from institutional establishment to collective operationalisation.

Medicines Regulation as Global Health Security

Ladies and Gentlemen,

The past few years have delivered a clear and unavoidable lesson:
medicines regulation is no longer a technical back-office function, it is a pillar of global health security and economic resilience.

The COVID-19 pandemic, recurring disease outbreaks, supply-chain disruptions, antimicrobial resistance and the growing threat of substandard and falsified medical products have exposed deep vulnerabilities in global health systems. For Africa, these shocks underscored a hard truth:

No continent can protect its population if it cannot effectively regulate the safety, quality and availability of medical products.

Strong regulatory systems are, therefore, not optional. They are strategic infrastructure, comparable to disease surveillance, laboratory networks and emergency preparedness systems.

The African Medicines Agency is Africa’s collective response to this reality, a response rooted in solidarity, science and sovereignty.

National Regulatory Authorities: The Backbone of AMA

National Regulatory Authorities are the backbone of the African Medicines Agency. Without strong, credible and well-resourced NRAs, AMA cannot succeed. Your expertise, legal mandates, regulatory decisions and data systems form the living foundation upon which AMA must be built.

AMA’s success will depend on:

• Trust between national authorities and the continental agency;
• Effective reliance and mutual recognition mechanisms;
• Transparent and predictable regulatory processes; and
• Respect for national sovereignty alongside continental coordination.

This Forum provides the space to align expectations, clarify roles and co-create operating models that serve all Member States, regardless of regulatory maturity or resource level.

The Role of Regional Economic Communities

Equally critical are our Regional Economic Communities, which have long served as the laboratories of regulatory harmonisation on the continent.

Experience under the African Medicines Regulatory Harmonisation (AMRH) initiative has demonstrated that:

• Regional collaboration reduces duplication;
• Accelerates access to quality-assured medicines; and
• Builds trust across borders.

The transition from AMRH to AMA is, therefore, not a rupture — it is an evolution.

RECs are not intermediaries to be bypassed. They are strategic partners, essential to:

• Joint assessments;
• Work-sharing arrangements;
• Capacity strengthening; and
• Bridging national realities with continental frameworks.

This Forum is a concrete step toward ensuring that regional gains are preserved, scaled and institutionalised within the AMA architecture.

From Deliberation to Delivery

Your discussions over the next two days, on regulatory reliance, capacity strengthening, clinical trials oversight, pharmacovigilance, digital transformation and regulatory maturity, will directly shape how AMA delivers on its mandate in practice.

They will also inform the development of an inclusive and forward-looking multi-year Strategic Plan for the Agency.

As we move forward, allow me to highlight six guiding principles for our collective work:

1. African Ownership – AMA must be driven by African priorities, expertise and accountability;
2. Scientific Excellence and Regulatory Integrity – credibility must remain our currency;
3. Inclusivity and Equity – no Member State should be left behind;
4. Efficiency and Value Addition – AMA must simplify, not complicate regulatory pathways;
5. Sustainability – long-term financing and Member States’ commitment are essential; and
6. Digital Transformation – modern regulation requires interoperable, data-driven systems.

AMA as a Development and Industrial Instrument

Excellencies,

The African Medicines Agency is not only a health institution, but also a development and industrialisation instrument.

By strengthening regulatory systems, AMA will:

• Support local pharmaceutical manufacturing;
• Enable innovation and technology transfer;
• Empower small and medium-sized enterprises; and
• Enhance Africa’s competitiveness in the global health economy.

In this regard, I welcome the establishment of the AMA SME and Innovation Office and encourage National Regulatory Authorities to work closely with the Agency to ensure that regulation acts as an enabler of innovation, while upholding the highest standards of quality, safety and efficacy.

There can be no effective single market for health products under the AfCFTA without regulatory convergence.

Political Commitment and Treaty Ratification

Distinguished colleagues,

Regulatory systems operate within political systems. While progress has been made in AMA Treaty ratification, we must now accelerate toward near-universal ratification and implementation.

Ratification:

• Strengthens AMA’s legal authority;
• Enables full participation; and
• Reinforces continental legitimacy.

I therefore call upon NRAs and RECs to act as advocates within your national systems, engaging Ministries of Health, Justice, Finance and Parliaments to advance this agenda.

Conclusion

As I conclude, I wish to remind us that, history will judge the African Medicines Agency not by the elegance of its legal texts, but by its impact on the lives of Africans, on whether a mother can access safe medicines, whether a child receives quality vaccines and whether Africa can respond decisively to the next health emergency.

That responsibility rests with all of us.

The African Union Commission reaffirms its full political support to the African Medicines Agency, to its Director-General, to its Governing Board and to each one of you. We stand ready to support, listen and act on the outcomes of this Forum.

Let us build an Agency that reflects the best of Africa’s expertise, the strength of its unity and the ambition of its people.

 Africa has waited long enough for a truly continental regulatory system.
The moment is now.
The tools are in place.
The responsibility is ours.

I wish you fruitful deliberations and every success in your discussions.

I thank you for your attention.