Regulatory systems play a central role in ensuring safe, effective, and quality-assured vaccines and other health products reach patients. Across Africa, these systems have been steadily strengthening. More national regulatory authorities are achieving higher maturity levels, and regional initiatives are expanding and accelerating product assessments. Supply chain resilience has become a political priority after COVID-19 exposed the risks of global dependence, and a robust regulatory ecosystem is now widely recognized as a foundational building block for Africa’s ambitions to expand regional vaccine manufacturing and reduce dependence on external suppliers.
Yet, access to quality-assured health technologies, including medicines and vaccines, in low- and middle-income countries (LMICs) still largely depends on a regulatory model designed for a different era—one where a single mechanism at the World Health Organization (WHO) was expected to validate the quality of nearly all health products procured for these countries. That system delivered major advances in global health gains. But in today’s landscape—with stronger LMIC regulators, growing regional manufacturing, shifting procurement patterns, and transitioning to domestic finance amid waning external aid—it is no longer fit for purpose.
For decades, the WHO’s Prequalification Programme (PQ) has served as the backbone of global quality-assurance. With sustained support from WHO, regulatory capacity has strengthened significantly across many LMICs, allowing more regulators to conduct high-quality product assessments. Africa demonstrates this shift: Nine African national regulatory authorities (NRAs) are now assessed by WHO as operating at “functional” maturity levels, and regional initiatives like ZaZiBoNa and the East African Community’s regulatory harmonization program have shown that joint reviews can dramatically shorten timelines. As regulatory capacity has strengthened, the traditional prequalification model has become less well aligned with current needs, particularly given its narrow scope, slow timelines, and tendency to duplicate prior assessments. Today, PQ often re-reviews products that have already been assessed by trusted regulators, including a WHO-Listed Authority (WLA) or an African regulator operating at maturity level 3 or 4 (ML3/4). This duplication results in long delays. The first mpox vaccine, for instance, was not prequalified until late 2024—nearly two years after the vaccine was available in Europe and the United States.
WHO has begun taking steps to update global regulatory processes, including a major draft revision to the Prequalification Programme released in March 2025, its most substantial update in 20 years. It introduces meaningful steps toward greater reliance mechanisms, where PQ builds on the assessments of trusted regulators instead of repeating them. While this presents a real opportunity to modernize the global regulatory system, key operational questions remain unresolved. Without broader reform, LMICs will continue to face multi-year delays in approving essential products, and regional manufacturers will remain locked out of regional and global markets. The WHO Executive Board meeting in February and the World Health Assembly in May offer an immediate opportunity to begin addressing these gaps.
A new CGD policy paper released today outlines what a more diversified, efficient, and regionally grounded regulatory system could look like. Below, we highlight practical shifts as part of a three-part reform agenda to support timely access, enable more regionally diversified production, and build a regulatory system better aligned with Africa’s needs.
1. Turn WHO Prequalification into a fast, reliance-based validator
WHO PQ remains a global public good, but its role must evolve. In recent years, WHO has introduced two important system-wide reforms. The Global Benchmarking Tool (GBT) assesses the capacity of national regulatory authorities and identifies those operating at a “functional” level. The WHO-Listed Authority (WLA) framework designates mature regulators whose decisions can be trusted and used for reliance. These reforms strengthen the foundation for a more distributed regulatory model, but they have not yet translated into faster pathways for LMICs or reduced duplication within PQ.
A modern PQ Program should shift toward reliance-based validation:
- No more full re-reviews: PQ should use an administrative listing function for WLA-authorized products and a 60-day desk review for products authorized by ML3/4 regulators. These pathways should initially apply to lower-risk, lower-complexity products—such as locally produced, quality-assured small-molecule generics—including products that fall outside PQ’s current eligibility scope.
- Proactive horizon-scanning: PQ should proactively track new approvals by WLAs and ML3/4 regulators and invite manufacturers that have already been approved by trusted authorities to submit dossiers.
- Waive inspections: If a recent Good Manufacturing Practice (GMP) audit was performed by a WLA, ML3/4 authority or PIC/S inspectorate, WHO should accept it without duplication.
These changes would shift PQ from a slow evaluator to a global registrar of trusted regulatory decisions—focusing on oversight, performance monitoring, and quality assurance across products’ life cycles, rather than duplicating reviews.
2. Diversify regional and national pathways
Relying solely on WHO PQ, or the handful of high-income regulators, no longer makes sense. Africa’s regulatory capacity is growing and African regulators and regional bodies are now capable of contributing directly to the global quality ecosystem. But the current system still treats most LMIC approvals as insufficient for global procurement—and many African manufacturers cannot even apply for PQ because their national regulators are not yet authorized to oversee vaccine production.
Three shifts would fix this imbalance:
- Broaden the use of alternative regulatory pathways: African governments, donors, and global health initiatives should embrace complementary routes beyond PQ, particularly for products not included in PQ’s current Expressions of Interest. This includes region-specific vaccines, new diagnostics, and medicines for noncommunicable diseases.
Regional Economic Communities, like the East African Community and the Southern African Development Community, should formalize joint reviews and upload their assessments directly through WHO’s Collaborative Registration Procedure, triggering a 60-day PQ desk review and streamlining national licensing.
- Expand the pool of trusted regulators: African ML3/4 authorities and strong regional networks should receive tailored support to reach WLA designation. Achieving WLA status in Africa would give the continent far more regulatory autonomy and help accelerate access to regionally important products.
- Adapt procurement rules: Global health initiatives such as UNICEF, the Global Fund, UNFPA, and Gavi currently restrict purchases of PQ- or WLA-approved products. These policies inevitably exclude products authorized through African reliance pathways or ML3/4 regulators, even when these approvals meet rigorous WHO standards.
Updating procurement rules to recognize reliance-based routes would: speed up tenders; expand options for local and regional manufacturers; reduce stock outs when PQ queues lengthen; and align procurement policies more closely with Africa’s manufacturing agenda.
3. Align downstream enablers: Transparency, data sharing, and legal reform
Even with upstream reforms, national and regional authorities cannot legally rely on the decisions of others, or if procurement rules ignore alternative pathways.
Three enablers are essential:
- Greater transparency from WLAs: Reliance only works if regulators can see what they are relying on. Many WLAs, including the FDA, however, do not publish key data such as clinical reports, GMP outcomes, and regulatory actions. Without this, LMIC regulators are forced to duplicate reviews.
- Legal pathways for mutual recognition: African governments must modernize regulatory laws so that regional decisions have real effect. A continental mutual recognition system anchored in the African Medicines Agency would allow approval across all participating countries, drawing from the European Medicines Agency’s centralized procedure and enabling automatic or near-automatic recognition across participating jurisdictions. This would result in faster access, fewer duplicative national reviews, and stronger regional oversight.
- Twinning and third-party certification: Twinning arrangements between WLAs and African ML3/4 authorities would accelerate capacity-building and harmonization. Meanwhile, third-party GMP auditing, similar to the Medical Device Single Audit Program, could relieve pressure on inspectorates and shorten registration timelines.
Together, these measures would make reliance feasible in practice.
A faster, more inclusive, and diversified regulatory system
The global regulatory system has delivered enormous public health gains. But it was built for a different moment—before LMIC regulators strengthened, before regional manufacturing became a strategic priority, and before pandemic shocks highlighted the fragility of global supply chains.
Today’s priorities require a system that is faster, more distributed, and better aligned with Africa’s regulatory realities.
A modernized, reliance-based PQ; diversified regional and national pathways; and aligned procurement, transparency, and legal frameworks provide a clear roadmap for reform. These changes would reduce duplication, support more regionally diversified production, and accelerate access to safe, effective, quality-assured health products across Africa.
With the WHO Executive Board convening in February and the World Health Assembly in May, global and regional leaders have a timely opportunity to move these reforms forward.
