AI in Drug Development: Global Standards Emerge, Africa Must not Be Left Behind

Mar 5, 2026 | Blog

On January 14, 2026, the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly released ten guiding principles for Good AI Practice (GAIP) in drug development (1). This landmark collaboration signals that artificial intelligence (AI) has definitively moved from experimental curiosity into regulatory priority.

The EMA announcement confirmed that these principles provide a high-level framework for responsible AI deployment across the entire medicines lifecycle, from early research through manufacturing and post-market surveillance (2). While this transatlantic alignment represents a significant step toward global regulatory coherence, it also raises an urgent question: Where does Africa stand, and what must the continent do to avoid being left behind?

Understanding the Joint Framework

The FDA-EMA principles are deliberately foundational and non-prescriptive, establishing a shared vocabulary upon which future binding guidance will be built. They emphasize a human-centric approach to AI design, ensuring that these technologies serve patients and healthcare professionals rather than replacing human judgment. Critically, the framework calls for risk-based approaches to development, clear definitions of “context-of-use,” and the integration of multidisciplinary expertise throughout the technology lifecycle. It stresses robust data governance, recognizing that AI systems are only as reliable as the data upon which they are trained.

This framework is not an isolated event; it builds directly upon the Good Machine Learning Practice (GMLP) principles published in 2021 by the FDA, Health Canada, and the United Kingdom’s Medicine and Health products Regulatory Agency (MHRA) (3). For African regulators, this lineage underscores a continuity of global thinking: principles come first, followed by specific regulatory mechanisms.

The African Regulatory Landscape

Africa is not starting from scratch. We have meaningful progress to leverage. The African Medicines Agency (AMA), established under the African Union, represents a continental commitment to harmonized regulatory standards (4). Furthermore, the African Medicines Regulatory Harmonization (AMRH) initiative has laid the groundwork for convergence (5).

Crucially, the continent’s regulatory capacity is maturing. A growing group of African National Regulatory Authorities (NRAs), including those in Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and Zimbabwe, now operate at World Health Organization (WHO) Maturity Level 3 (ML3) (6). These nations are already formalizing reliance through multi-country agreements (7).

Beyond pharmaceuticals, we have the policy architecture for data governance. The African Union’s Digital Transformation Strategy (2020–2030) and the now active Malabo Convention on Cyber Security and Personal Data Protection provide the necessary legal backbone for data stewardship (8,9). These are the tools we must now operationalize for AI in health.

A 10-Point Plan: What Africa Should Be Doing Now

The FDA-EMA joint principles offer Africa a template, but we must adapt, not just adopt. To move from “not being left behind” to “leading with purpose,” we propose the following actions:

  1. Stand up an AMA-led “AI in Medicines” Working Group: We need a dedicated body to translate global GAIP into Africa-adapted principles, clarifying how risk-based oversight applies in resource-constrained settings.
  2. Build an African Regulatory Science Curriculum: African professionals need tiered training on understanding model development, verifying data lineage, and interrogating algorithmic bias.
  3. Require Evidence in African Populations: Regulators should expect applicants to demonstrate AI performance on representative datasets. Where AI tools influence safety or efficacy, we must avoid miscalibration caused by training exclusively on non-African populations.
  4. Operationalize Data Governance via Malabo: We must develop guidance for data controllers on the lawful, ethical use of clinical data for AI, using the Malabo Convention as the continental anchor.
  5. Create Regional Assessment Hubs: Regional Economic Communities (RECs) should designate technically equipped nodes to conduct joint AI-specific assessments and run regulatory sandboxes.
  6. Publish a “Technical Dossier” Checklist: Borrowing from GAIP, we need clear expectations for data provenance, version control, and drift monitoring to enable predictable reviews.
  7. Invest in Secure Digital Infrastructure: We need funded, secure data rooms and compute environments that allow NRAs to review sensitive model artefacts without unnecessary data copying.
  8. Leverage South–South Cooperation: We should establish technical exchanges with mature regulators in the Global South to share AI review practices and tooling.
  9. Strengthen Financing: Development partners must prioritize grants for regulatory digitization; credible AI oversight is impossible without digital infrastructure.
  10. Communicate Transparency: We must publish plain-language summaries when AI-enabled approaches are approved, explaining safeguards to patients and professionals.

Call to Action: What This Means for Stakeholders

Translating these principles into practice requires immediate action across the ecosystem. For regulators, the priority is to move from theory to implementation by launching a dedicated AI-in-Medicines workplan for 2026–2027 and piloting joint AI validation reviews. To support this, funders and development partners must direct critical resources toward upskilling assessors and building the secure compute environments necessary for independent oversight.

Simultaneously, industry developers must plan for representative data early in the lifecycle; this means budgeting specifically for post-market performance monitoring in Africa rather than relying solely on extrapolation from high-income settings.

Finally, the Africa Clinical Research Network (ACRN) stands ready to act as a trusted pan-African coordination platform. We are committed to convening this agenda, brokering technical exchanges, and hosting an open repository of AI regulatory tools to ensure the continent is prepared for this new era.

Conclusion

The FDA-EMA joint principles mark a defining moment. For Africa, this is an opportunity to leapfrog traditional regulatory pathways by building AI-ready systems now. Success requires political commitment, resource allocation, and strict adherence to our own ethical baselines.

The alternative, regulatory marginalization in an AI-driven landscape, is a risk Africa cannot afford to take. By combining global standards with African data sovereignty and the Malabo Convention frameworks, we can ensure that emerging technologies truly serve African patients.

Reference List

  1. Research C for DE and. Guiding Principles of Good AI Practice in Drug Development. FDA [Internet]. 2026 Jan 14 [cited 2026 Feb 10]. Available from: https://www.fda.gov/about-fda/artificial-intelligence-drug-development/guiding-principles-good-ai-practice-drug-development
  2. EMA and FDA set common principles for AI in medicine development | European Medicines Agency (EMA) [Internet]. 2026 [cited 2026 Feb 10]. Available from: https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0
  3. Health C for D and R. Good Machine Learning Practice for Medical Device Development: Guiding Principles. FDA [Internet]. 2025 Dec 19 [cited 2026 Feb 10]. Available from: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles
  4. African Medicines Agency (AMA) | AUDA-NEPAD [Internet]. [cited 2026 Feb 10]. Available from: https://www.nepad.org/microsite/african-medicines-agency-ama
  5. AMRH Home | AUDA-NEPAD- AMRH [Internet]. [cited 2026 Feb 10]. Available from: https://amrh.nepad.org/
  6. List of National Regulatory Authorities (NRAs) operating at maturity level 3 (ML3) and maturity level 4 (ML4) [Internet]. [cited 2026 Mar 5]. Available from: https://www.who.int/publications/m/item/list-of-nras-operating-at-ml3-and-ml4
  7. Landmark Agreement Among Africa’s Leading National Medicines Regulatory Authorities to Foster Collaboration. Africa CDC [Internet]. [cited 2026 Mar 5]. Available from: https://africacdc.org/news-item/landmark-agreement-among-africas-leading-national-medicines-regulatory-authorities-to-foster-collaboration/
  8. 38507-doc-DTS_for_Africa_2020-2030_English.pdf [Internet]. [cited 2026 Feb 20]. Available from: https://digitaltransformationcar.org/assets/docs/38507-doc-DTS_for_Africa_2020-2030_English.pdf
  9. Ayalew YE. The African Union’s Malabo Convention on Cyber Security and Personal Data Protection enters into force nearly after a decade. What does it mean for Data Privacy in Africa or beyond? EJIL: Talk! [Internet]. 2023 Jun 15 [cited 2026 Feb 20]. Available from: https://www.ejiltalk.org/the-african-unions-malabo-convention-on-cyber-security-and-personal-data-protection-enters-into-force-nearly-after-a-decade-what-does-it-mean-for-data-privacy-in-africa-or-beyond/