Cleared backlog of applications for biological medicines in South Africa
in South AfricaTrade barrier summary
Delays in processing post‑authorisation variation applications for biological medicines at South Africa’s medicines regulator, SAHPRA, had created uncertainty for UK life sciences companies exporting to the South African market. The issue affected complex biological products, including vaccines, and reflected historic regulatory backlogs linked to capacity constraints rather than changes in policy or legislation.
With support from the UK government’s Ricardo Fund, SAHPRA cleared the backlog of affected biological medicine variation applications within the agreed project timeframe. The support was time‑bound and focused on restoring regulatory throughput while respecting SAHPRA’s independence and governance arrangements.
This has improved regulatory predictability for UK exporters by reducing delays to approved biological medicines and providing greater certainty when planning product updates or manufacturing changes.
Sectors affected
- Pharmaceuticals and biotechnology
- Healthcare services
Resolved
Yes - April 2026
Date reported
16 February 2024
Last updated
20 May 2026
Public ID
PID-B6XW7G
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