African Medicines Agency Treaty Ratification and SAHPRA Strengthening
Theme: Medicines regulation
Assessment
Responsible: South African Health Products Regulatory Authority / Department of Health / Department of International Relations
Feasibility Assessment
High feasibility for SAHPRA-specific reforms within existing legislative mandate. AMA integration pathway is longer-term and depends on AU member state buy-in. Key constraint: SAHPRA budget adequacy and staff retention in competition with private pharma industry.
Description
The African Medicines Agency (AMA) was established under the African Union framework and opened its headquarters in Yaoundé, Cameroon in 2021 after South Africa ratified the AMA Treaty. SAHPRA (South African Health Products Regulatory Authority) — one of Africa's most technically sophisticated medicines regulators — is positioned as a reference regulatory authority for the AMA framework, able to provide registration reliance mechanisms that allow other African countries to benefit from SAHPRA's rigorous reviews. SAHPRA's 2025-2030 Strategic Plan and 2025/26 Annual Performance Plan outline priorities including: implementing a fully risk-based assessment approach, reducing registration backlogs (critical for NHI benefit package design), strengthening post-market surveillance, and combating the proliferation of counterfeit pharmaceuticals and medical devices. On 30 September 2025, South Africa launched a National Action Plan on Substandard and Falsified Medical Products in partnership with WHO. SAHPRA is also refining its eCTD dossier submission standards and labelling requirements to align with international ICH guidelines, critical for attracting pharmaceutical manufacturers to register in South Africa as a gateway to African markets. The AMA-SAHPRA relationship represents South Africa's most concrete contribution to African health system integration under the AU Agenda 2063 framework.
South Africa's ratification of the AMA Treaty and SAHPRA's position as a reference regulatory authority creates the institutional architecture for safe, accessible medicines across Africa — but SAHPRA needs sustained investment to fulfil this role. — SAHPRA Strategic Plan 2025-2030
Implementation Roadmap
South Africa has ratified the AMA Treaty and SAHPRA is positioned as the continent's lead reference regulatory authority. The implementation agenda focuses on: (1) clearing SAHPRA's registration backlog through risk-stratified review lanes (critical for NHI benefit package design); (2) operationalising AMA reliance mechanisms that allow other African countries to rely on SAHPRA reviews, reducing continental regulatory duplication; and (3) combating the proliferation of substandard and falsified medicines under the September 2025 National Action Plan.
SAHPRA backlog clearance programme: implement risk-stratified review lanes — expedited for essential medicines and NHI benefit package medicines (target 90 days), standard for generics, enhanced review for novel biologicals and advanced therapy medicinal products
Operationalise AMA reliance mechanism: develop a standard SAHPRA assessment package format compatible with AMA harmonised dossier requirements; onboard 5 African countries as initial reliance partners (Ghana, Kenya, Tanzania, Zimbabwe, Botswana)
Implement WHO Collaborative Registration Procedure (CRP): fast-track registration of all WHO-prequalified medicines to a maximum of 90 days (current average is 18 months) through a ministerial regulatory amendment
Parliamentary record
11 meetingsCommittee sittings this reform was drawn from, most recent first. Each row opens the meeting on this site; the PMG link goes to the source record.
How to cite
Wilse-Samson, L. (2026). African Medicines Agency Treaty Ratification and SAHPRA Strengthening. SA Policy Space. Retrieved 24 August 2026, from https://sa-policy-space.vercel.app/ideas/african-medicines-agency-treaty-ratification-and-sahpra-strengthening?snapshot=2026-08-24
Status History
tracked since Mar 2026- Recorded as Under review when status tracking began — held since at least Mar 2026.Mar 2026
Data as of 2026-08-24 · latest PMG meeting 2026-08-21