Africa’s cities, economies and populations are booming. Perhaps Professor Washington Yotto Ochieng summed up the opportunities available across the continent most succinctly: “There are two future big things. One is space, and one is Africa.”

But to capitalise on the young population and accelerating urbanisation in the world’s only emerging market, the governments of Africa’s 55 countries must build trust with their people. Health – more precisely, access to standardised, quality health technologies – is foundational to this dynamic.

This is where the Africa Medicines Agency (AMA) comes in.

At the moment, as it was in Europe before the European Medicines Agency was established, each country on the continent has its own set of rules, regulations and standards. This presents logistical and cost challenges to African and global industry trying to build markets for their products across the continent.

Disparate policies mean regulatory and administrative processes can become prohibitive for business, while the logistics and costs associated with bringing products to market in individual countries mount. This has several knock-on effects.

First, it discourages both local and international investors from setting up manufacturing. Building markets across the continent is difficult, but the lack of standardisation makes it harder. It limits competition and leaves gaps in manufacturing capacity, creating serious risks to continental and global health security when pandemics occur.

Gaps or inconsistencies in regulatory systems also create space for substandard and falsified medicines to thrive. The tragic deaths of at least 66 children in the Gambia in 2022 linked to contaminated cough syrups made in India are a stark reminder of what is at stake. Strong systems for quality assurance and safety monitoring are essential to prevent such events and maintain public trust.

With Africa’s pharmaceutical market projected to exceed $50 billion by 2030, the opportunities are clear: manufacturing medical products on the continent can strengthen supply, reduce dependency, create jobs, and boost health.

But getting to this point requires strong, predictable regulatory systems.

Established by African Union member states, AMA is working to do just that. We aim to strengthen regulatory oversight, reduce fragmentation and build trust in medical products across the continent, with three key priorities.

To begin with, AMA aims to harmonise and streamline how medical products are assessed and approved. By aligning standards and reducing duplication, we will help ensure that safe, effective, medical products reach patients faster. Other regions – particularly the US with the Food and Drug Administration (FDA) and the European Medicines Agency in the EU – have shown what is possible, but Africa’s approach is obviously being shaped by its own needs and realities.

This is a win for local and international manufacturers alike. Instead of 55 national regulatory systems, they will have to go through just one process to get their products to market – with huge savings in terms of time, human capital and expenditure.

Second, we want to make this truly pan-continental. So far, thirty-one countries have ratified the AMA Treaty – it’s a strong start, but not enough for our ambition to create a full continental market. We call on all Member States to act: universal ratification is critical to unlock scale, attract investment and support the growth of local manufacturing.

As well as joining the AMA, it’s now time for leaders throughout the continent to accelerate convergence to support a continental medicines regulatory system and also back it financially through predictable, timely contributions embedded within national budget cycles. It’s an investment today and for the future.

Third, as Africa builds up its manufacturing capacity, strong regulation is essential to ensure that medicines are safe and effective, to support innovation, and to create the confidence needed for long-term investment. Improving oversight and coordination, AMA will ensure that medical products across Africa meet high standards with robust continental quality and safety monitoring systems, enabling faster, more decisive action when needed.

While space provides infinite opportunities, Africa, a continent with more than 1.5 billion people, has the opportunity to take the next step in its growth story. Of the top 15 fastest growing countries in 2026, 11 are projected to be in Africa. In terms of population, the continent is the world’s fastest growing and by 2050, the population is expected to be 2.5 billion people. In that period, 350 million people are projected to move to cities.

The potential is clear, and regulation can help us maximise it. With clear, robust systems, the continent can accelerate access to life-saving medical products, support innovation and strengthen its role in global health. For patients, this means faster access, greater confidence, and better outcomes when it matters most.

The world’s health system is only as strong as its weakest part and by strengthening Africa’s core regulatory pathways, we intend to strengthen global health security for all.

Dr Delese Mimi Darko is Director General of the African Medicines Agency

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