Where PV Regulation in Africa is Headed: Insights for 2026

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This is the third year in a row that I am providing an outlook on PV regulations in Africa. To refresh your memory, here are the editions for 2024 and 2025. I thought I would begin my 2026 Outlook by reassessing the 2025 predictions; what I got right, and where I missed the mark.

Here are a few that stand out:

WHO ML3. I predicted that more National Competent Authorities (NCAs) in Africa would achieve ML3. In reality, only one—Ethiopia—achieved this milestone. However, several countries, including Kenya and Uganda, underwent WHO assessments this year. I believe they are on track to reach ML3. The push toward ML3 is prompting more NCAs to become increasingly stringent in enforcing PV regulations on MAHs.

Operationalisation of the African Medicines Agency (AMA). With this, I hit the nail right on the head AMA is now fully established, with a CEO appointed. Its vigilance technical committee has begun its work, and AU PRAC is being formed, as you will see in the 2026 outlook.

African Union Model Law on Medical Products Regulation. I predicted that more countries would domesticate this law. Uganda did—its parliament tabled the National Drug and Health Products Authority Bill, 2025. You can read my analysis of the bill here.

Medical device vigilance guidelines. I anticipated that more countries would establish guidelines on the vigilance of medical devices. Indeed, SAHPRA’s Post-Market Surveillance and Post-Market Clinical Follow-Up Studies guideline became effective this year.

PV outsourcing. On this one, I was right in the middle of it. This year, I received an increased number of requests for proposals from MAHs and PV vendors for PV services across Africa. I expect these numbers to only increase even more.

Readers of this newsletter are welcome to write their own commentary, draw different conclusions or leave me a question about my 2025 predictions.

Outlook for 2026

Integrated Regulatory Information Management Systems (IRIMS)

Traditionally, IRIMS have been used by NCAs to license pharmaceutical outlets, issue import and export permits, and manage dossier submissions. In 2026, I expect more NCAs  to as well integrate PV processes such as ICSR submission, aggregate safety reporting, and LQPPV nomination into their IRIMS platforms.

We saw early signs of this in April, when Kenya’s Pharmacy and Poisons Board (PPB) required MAHs to submit ICSRs and PSURs through its Pharmacovigilance Electronic Reporting System (PvERS). Uganda’s IRIMS already contains inactive modules for registering LQPPVs and submitting ASRs. I expect these to be fully rolled out in 2026.

Vigilance Technical Committee (V-TC)

The Vigilance Technical Committee was inaugurated in November 2024 to support the operationalisation of vigilance-related regulatory functions under the AMA. It held its second meeting in August this year, where discussions focused on harmonised tools for GVP inspections and RMP assessments.

In 2026, the V-TC is expected to continue influencing NCA operations across Africa. MAHs should anticipate more GVP inspections and increased requests for RMP submissions.

AU PRAC

In July 2025, the African Union Smart Safety Surveillance (AU-3S) programme under AUDA-NEPAD issued a call for expressions of interest to join the African Union Pharmacovigilance Risk Assessment Committee (AU-PRAC).

The AU-PRAC will provide expert opinions on identified safety signals, conduct benefit–risk assessments of priority medical products, and recommend risk minimisation measures and regulatory actions to NCAs, the V-TC and AMA.

I expect AU-PRAC to become fully operational in 2026. Priority products include those for HIV, malaria, TB, polio, maternal health, and emerging diseases such as MPOX, Lassa fever, Respiratory Syncytial Virus (RSV) and Group B Streptococcus. MAHs working with these products should expect more assessment reports and requests for additional risk minimisation measures.

PV Reliance

Traditionally, African NCAs have relied on other regulators for functions such as marketing authorisation and GMP inspections. PV, however, has largely been absent from reliance discussions. I expect this to change in 2026.

This month, the Egyptian Drug Authority (EDA) published the second version of its Guideline on Reliance Practices for Pharmacovigilance. I anticipate that the V-TC will encourage other NCAs to develop similar guidelines in 2026.

PV reliance for MAHs may look like this:

• Local NCAs using safety and efficacy information from other authorities to mandate label changes and implement additional risk minimisation measures.
• Abridged assessments of PSURs, RMPs and PSMFs using assessment reports from WHO Listed Authorities such as EMA, MHRA, FDA and PMDA.

Certification for PV Professionals

A few weeks ago, I was invited to participate in a survey on establishing the College for African Medical Products Regulatory Science Professionals (CARSP). CARSP aims to professionalise regulatory science, address human-resource gaps, and create structured pathways for accreditation, training, and continuous professional development across Africa.

In 2026, there will be a concerted effort to operationalise CARSP. Once established, I expect NCAs to require MAHs’ PV staff to obtain CARSP certification.

The Institute of Pharmacovigilance is also rolling out its certification programmes in 2026, which Uganda’s NCA has already hinted at recommending to LQPPVs.

Regulatory Actions for PV Non-Compliance

In 2025, NCAs in Kenya, Ethiopia and Zambia issued directives requiring MAHs to comply with PV regulations or risk product suspension. I’ve said it many times, and I’ll repeat it: the threat of product suspension is the only language MAHs truly listen to. It is working and MAHs are indeed responding.

In 2026, expect more such directives from other countries.

AI & PV

Earlier this month, CIOMS published its report on Artificial Intelligence in Pharmacovigilance. While I do not expect African NCAs to release AI-specific PV guidelines in 2026, I believe the report will spark discussions among PV stakeholders regarding how both regulators and industry can adopt AI in their processes.

Concrete guidelines are more likely in the coming years, as the use of AI in PV continues to evolve.

Conclusion

The regulatory landscape for pharmacovigilance in Africa continues to evolve at an accelerated pace, driven by strengthening continental institutions, increasing regulatory convergence, and a growing emphasis on accountability among Marketing Authorisation Holders. While progress remains uneven across Member States, the developments anticipated for 2026 — ranging from the operationalisation of AU-PRAC and expanded IRIMS functionality to the emergence of PV reliance frameworks and professional certification pathways — signal a decisive shift toward more harmonised, rigorous, and technologically informed PV systems.

For MAHs, the direction of travel is clear: compliance expectations will rise, regulatory oversight will intensify, and proactive engagement with emerging requirements will become essential. For regulators, collaboration and capacity strengthening will be central to sustaining momentum and ensuring that PV systems remain responsive to Africa’s rapidly evolving public health priorities.

Taken together, the trends outlined in this outlook point to a maturing regulatory environment that is increasingly capable of safeguarding patient safety and supporting the effective use of medical products across the continent. The coming year will undoubtedly present challenges, but it also offers significant opportunities to consolidate recent gains and advance a more coordinated and resilient pharmacovigilance ecosystem for Africa.

Written by

Odokonyero Kennedy

Pharmacist, Global Shaper at Kampala Hub and student of Msc. Pharmaceuticals and Health Supplies Management at Makerere University. [email protected]

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