Skip to main content
SA Policy Space

African Medicines Agency Treaty Ratification and SAHPRA Strengthening

Regulatory BurdenUnder reviewQuick WinRaised 11× in committeeHealth

Theme: Medicines regulation

First raisedNov 2021Last discussedOct 2025No committee discussion in 12+ months11 meetings on the record ↓
Generate BriefCompareFeasibility Matrix

Reform at a glance

What changes
African Medicines Agency Treaty Ratification and SAHPRA Strengthening
Responsible actor (recorded)
South African Health Products Regulatory Authority / Department of Health / Department of International Relations
Recorded status
Under review — editorial assessment.
Milestone described by this status
Status scope has not yet been independently documented; it may cover only part of this reform.
Next documented milestone
Next milestone not yet documented
Compare shortlist (0/3)
Back to ideas
On this page

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.

Assessment

Growth Impact3/5
Feasibility4/5

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.

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.

1

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

Q1 2026–Q4 2027SAHPRA Medicines Evaluation and Registration Division / Department of Health
2

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)

Q1–Q4 2026SAHPRA / AMA Secretariat (Yaoundé, Cameroon) / DIRCO
3

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

Q1 2026 (regulatory process change only — no legislation required)SAHPRA Medicines Evaluation and Registration Division
4

National Action Plan on Substandard and Falsified Medical Products: implement joint WHO-SAHPRA action plan (launched 30 September 2025); establish a rapid alert system linked to Interpol Project Pangea and the WHO Global Surveillance and Monitoring System

Q4 2025–Q4 2026SAHPRA / Department of Health / SAPS / Interpol National Central Bureau
5

eCTD dossier standardisation: complete migration to ICH eCTD v4.0 submission standard; publish updated labelling requirements aligned with ICH E3/E6 guidelines; attract international pharmaceutical manufacturers to use SA as their African market gateway registration jurisdiction

Q2 2026–Q2 2027SAHPRA / ICH observer status engagement
6

NHI benefit package medicines registration priority lane: SAHPRA and the National Department of Health to jointly identify medicines proposed for the NHI benefit package and establish a dedicated fast-track review process with a 90-day target

Q1 2026–Q4 2027SAHPRA / National Department of Health / NHI Implementation Office
Timeline

18 months to full AMA reliance operationalisation and material backlog reduction (Q1 2026–Q2 2027)

Estimated Cost

SAHPRA annual budget R350 million (2025/26); backlog clearance requires an additional R80 million/year for temporary reviewer capacity (contract pharmacists and clinical evaluators); AMA reliance programme R25 million/year for technical assistance and capacity sharing with partner regulatory authorities

Required Legislation

AMA Treaty ratified (complete). SAHPRA established under the South African Health Products Regulatory Authority Act 35 of 2015. No new primary legislation required. Regulatory amendments needed under the Medicines and Related Substances Act 101 of 1965: SAHPRA Regulations on fast-track registration lanes and WHO CRP implementation — published as Government Notice by the Minister of Health.

Political Feasibility

SAHPRA strengthening has strong cross-party support and strong international support (WHO, African Union, Bill and Melinda Gates Foundation). NHI political dynamics are more complex — SAHPRA's role in NHI benefit package design is contested by private sector interests, but the AMA reliance mechanism is operationally separate from NHI. Department of Health credibility post-COVID vaccine rollout (net positive despite distribution challenges) supports the reform agenda. Budget constraints are the main risk — SAHPRA is structurally under-resourced relative to the regulatory burden it carries.

International Precedents

Tanzania's TFDA became an AMA reliance pioneer: fast-tracked registration of over 200 medicines in 2023 using SAHPRA review packages, reducing average registration time from 24 months to 6 months for those products. Ghana FDA's WHO CRP implementation (2022): 93 essential medicines registered in 90 days, used as the WHO model for African regulatory capacity. Australia's TGA reliance on European EMA assessments (2016) reduced duplication effort by 60% while maintaining Australian-specific safety standards — the direct operational model for SAHPRA's AMA reference authority role.

Evidence & Research

No linked research evidence yet. Coverage is incomplete.

Policy documents

No linked official-document evidence yet. Coverage is incomplete.

Get the Monday briefing by email

— A short weekly digest of what moved in SA policy.

Status History

tracked since Mar 2026
  1. Recorded as Under review when status tracking began — held since at least Mar 2026.
    Mar 2026

Data as of 2026-10-10 · latest PMG meeting 2026-10-02