Can Africa’s New Strategy Make Medicines Safer and Strengthen Local Drug Production?

Africa’s 2026–2035 strategy aims to strengthen medical product regulation through capable national authorities, digital systems, shared assessments and deeper regional cooperation. Successful implementation could protect patients, accelerate access to quality-assured products, support local manufacturing and improve preparedness for future health emergencies.

African health ministers have endorsed a decade-long strategy to strengthen the regulation of medicines, vaccines, diagnostic tests, blood products and medical devices, placing patient safety at the centre of the continent's health and pharmaceutical ambitions.

The Regional Strategy on Regulation of Medical Products in the African Region (2026–2035) arrives as governments seek to expand universal health coverage, increase local manufacturing and prepare health systems for future emergencies. These goals depend on more than producing or procuring additional health products. Countries must also be able to verify that every product reaching patients is safe, effective and manufactured to an acceptable standard.

Regulatory capacity has improved, supported by the African Medicines Regulatory Harmonization initiative and the operationalization of the African Medicines Agency. The number of national regulatory authorities reaching World Health Organization Maturity Level 3, a benchmark for stable, well-functioning regulatory systems, increased from one in 2018 to eight in 2025. However, most countries still require significant capacity development.

Patient Safety Becomes a Continental Health Priority

Medical product regulation is largely invisible to the public, but it influences almost every interaction between patients and health systems. Regulators assess applications, inspect manufacturing facilities, authorize products, monitor adverse reactions and investigate potentially falsified or substandard supplies.

Weak oversight can expose patients to ineffective treatments, undermine vaccination and disease-control programmes, and waste limited public health budgets. It can also damage confidence in hospitals, pharmacies, manufacturers and government procurement systems.

The strategy therefore connects regulatory reform with broader public health goals. Strong national authorities could help governments purchase reliable products, improve treatment outcomes and prevent scarce resources from being spent on supplies that fail to meet required standards.

The urgency is particularly clear during disease outbreaks. COVID-19 demonstrated how rapidly demand for vaccines, diagnostics, medicines and medical equipment can increase. Regulators must be capable of accelerating assessments during emergencies without abandoning scientific scrutiny or patient safeguards.

Building this capacity will require more than policy declarations. Countries need trained personnel, functioning laboratories, reliable safety-monitoring systems and clear procedures for emergency authorization. They must also maintain oversight after products enter the market, when previously unidentified risks may emerge.

Shared Assessments Could Break the Cycle of Duplication

A major element of the strategy is deeper cooperation among national and regional authorities. Joint product assessments, shared inspections and reliance on decisions made by trusted regulators could reduce the repeated evaluation of the same products across multiple countries.

This approach could be especially valuable for smaller or less-resourced authorities facing shortages of technical specialists. Instead of attempting to develop every capability independently, countries could pool expertise and direct limited resources towards national priorities such as market surveillance, enforcement and patient-safety monitoring.

Greater alignment could also help quality-assured products reach patients sooner. Manufacturers currently navigating different procedures, documentation requirements and timelines across national markets may benefit from more predictable regional pathways.

However, regulatory cooperation will require legal clarity and institutional trust. Governments must decide when they can rely on another authority's assessment and establish who remains accountable when safety or quality problems arise. Differences in national laws, technical capacity and political commitment could slow the recognition of shared decisions.

The African Medicines Agency could help coordinate this system, but its effectiveness will depend on cooperation with national regulators and existing regional initiatives. Clear responsibilities will be necessary to prevent overlapping mandates from creating another layer of administrative complexity.

Local Manufacturing Faces Its Quality Test

The regulatory strategy is closely tied to Africa's push to manufacture more medicines, vaccines and health technologies locally. Strong and credible oversight can give governments, healthcare professionals and patients greater confidence in African-made products.

Consistent standards could also improve the investment environment. Manufacturers able to demonstrate compliance may gain easier access to several national markets, increasing production scale and strengthening the commercial case for investment in factories, laboratories, workforce development and supply chains.

At the same time, higher standards will create new demands. Manufacturers may need to upgrade facilities, strengthen quality-management systems, improve documentation and recruit technically qualified employees. Smaller producers could find these compliance costs difficult to absorb.

Policymakers will consequently have to balance industrial development with regulatory independence. Supporting local manufacturing cannot mean lowering safety requirements or approving products primarily because they are produced domestically. Governments and development institutions may instead need to help capable manufacturers finance upgrades while ensuring that regulators remain protected from political and commercial pressure.

Digital systems could accelerate applications, safety reporting and cross-border information exchange. But technology alone will not resolve institutional weaknesses. Poor data quality, incompatible platforms, cybersecurity risks and shortages of trained staff could limit its impact. Unequal investment could also widen the gap between stronger regulatory authorities and countries struggling with basic infrastructure.

Implementation Will Decide Who Benefits by 2035

For African policymakers, the strategy creates a demanding national agenda. Governments will need to align legislation, provide sustainable budgets, strengthen laboratories and retain specialized staff. Without domestic financing, reforms may remain dependent on external projects that are difficult to maintain.

Development partners can support training, infrastructure and digital modernization, but their assistance should reinforce nationally owned systems rather than create disconnected platforms. Private manufacturers will gain from clearer rules and larger markets, although they will also face closer scrutiny and potentially higher compliance costs.

Patients and healthcare workers stand to benefit most if unsafe products are detected earlier and trusted treatments become available faster. Procurement agencies could also make purchasing decisions with greater confidence, reducing financial losses associated with poor-quality supplies.

Progress should therefore be measured through outcomes rather than announcements: scientifically credible approval timelines, stronger inspections, effective post-market surveillance, faster action against unsafe products and greater public confidence.

By 2035, the strategy's success will not be determined simply by the number of authorities reaching international benchmarks or the quantity of digital platforms installed. Its real test will be whether every African patient, regardless of country or income, can trust the medicines and health technologies on which their life depends.