SAHPRA Annual Report: Clean Audit and WHO ML3 Vaccine Milestone
September 22, 2026
The SAHPRA annual report for the 2025/26 financial year shows South Africa’s medicines regulator delivering a clean audit and reaching new global regulatory milestones. SAHPRA met 20 of 28 planned targets (71%), secured World Health Organization (WHO) maturity level 3 (ML3) for vaccines, and joined the International Council for Harmonisation (ICH).
Key indicators from the SAHPRA annual report
| Indicator | Target | 2025/26 result |
|---|---|---|
| APP targets achieved | 28 | 20 (71%) |
| New chemical entity master applications | 60 | 94 |
| Generic master applications | 420 | 376 (90%) |
| Type II variations within 200 working days | 50% | 82.48% |
| Lot release within 50 working days | 90% | 98% |
| GWP licences within 125 days | 70% | 70% |
| Recalls published within 7 days | 80% | 82% |
| Medical device establishment licences within 90 days | 80% | 133% |
Regulatory milestones
SAHPRA sits among a short list of African regulators holding the WHO ML3 ranking for vaccines. The authority was also named a Regional Centre of Regulatory Excellence (RCORE) across all nine regulatory functions in the WHO Global Benchmarking Tool framework, including lot release. It has been building vaccine regulatory oversight since 2024, with the goal of completing the milestone by 2026.
ICH membership followed an assessment of SAHPRA’s compliance and a presentation of its progress implementing ICH principles. The authority kept its ISO 9001:2015 certification and completed a PIC/S reassessment in June 2025, filing its corrective and preventive action response in October 2025. Continental work continued through ZAZIBONA and the African Medicines Agency, where reliance pathways shorten review timelines. SAHPRA deepened that regulatory collaboration across the continent and beyond.
On the vaccine side, lot release held up well. Of 182 requests due for finalisation, 178 (98%) were completed within 50 working days, above the 90% target. This sits alongside SAHPRA’s broader push on vaccine registration.
Backlog and authorisation throughput
SAHPRA finalised 94 new chemical entity (NCE) master applications against a target of 60. The authority credits stronger evaluation timelines and better coordination between technical units. Generic master applications reached 376 against a target of 420, or 90% of the annual goal, held back by competing priorities in the Inspectorate during backlog clearance in January and February 2026.
Phase 2 of the backlog project closed out during the year. Phase 1 and phase 2 cut the applications backlog by 81% and 54% respectively, and phase 3 began on 1 April 2026 with 340 ring-fenced applications. Type II variations finished at 82.48% (358 of 434) within 200 working days, well above the 50% target.
Medical devices and radiation control
The medical devices unit finalised 133% of its establishment licence target within 90 working days and ran a phase I feasibility study for high-risk Class C and D product registration, receiving 20 technical dossiers and recommending 9 products for approval. An updated draft of the medical device regulations went to the National Department of Health, and a guideline on artificial intelligence and machine learning (AI/ML) enabled devices was published in September 2025. SAHPRA is also testing the medical device registration pathway ahead of full implementation.
Workforce and capacity
The workforce grew from 331 to 376 employees during the year, with 82% of budgeted positions (106 of 129) filled. Turnover stayed at 7.4%, below the 10% target. SAHPRA acknowledged that scarce technical skills remain hard to attract and retain, and it uses external grant funding as an interim route to appoint staff on fixed-term contracts before absorbing them onto funded positions.
Source: SAHPRA Annual Report 2025/2026
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