SAHPRA accelerated approval oncology: What You Need to Know

Key Takeaways

• Regulatory distinction: SAHPRA's Priority Review (updated December 2023) expedites assessment but requires complete efficacy data, unlike FDA Accelerated Approval which permits conditional authorization based on surrogate endpoints like objective response rate. SAHPRA Priority Review Guidance
• FDA program scale: Since 1992, the FDA has granted 194 accelerated approvals in oncology—60% of all such approvals— with 125 granted in the last decade (2013-2022) alone. FDA ODAC Briefing Document
• Post-approval outcomes: Among 167 accelerated approval oncology indications (1992-2022), 61% converted to regular approval while 19% were withdrawn by August 2024; median time to verification is 3.1 years. eClinicalMedicine
• Patient access impact: South African oncology patients face delayed access to therapies available in markets with accelerated pathways, potentially forcing reliance on personal importation or international medical travel.
• Regional momentum: The February 2025 African NRA Memorandum of Understanding aims to harmonize regulatory decisions and may create framework for future accelerated pathways. SAHPRA News

What Is SAHPRA's Current Regulatory Framework?

The South African Health Products Regulatory Authority (SAHPRA) serves as the national regulatory authority for medicines, medical devices, and in vitro diagnostics. Its mandate centers on ensuring safety, efficacy, and quality of health products available in South Africa.

In December 2023, SAHPRA published Version 3 of its Priority Review Requests Communication. This policy provides expedited assessment for medicines treating serious diseases that address unmet clinical needs, serve orphan populations, or address national health priorities guided by the National Department of Health.

However, SAHPRA Priority Review differs fundamentally from FDA Accelerated Approval. Priority Review shortens the timeline for assessing a complete dossier that includes full evidence of quality, safety, and efficacy. It does not permit conditional authorization based on surrogate endpoints reasonably likely to predict clinical benefit.

How Does FDA Accelerated Approval Work?

The FDA established its Accelerated Approval program in 1992 by regulation in response to the HIV/AIDS crisis, later codifying it into law under the FDA Safety and Innovation Act (FDASIA) of 2012. The program allows earlier approval of drugs for serious conditions with unmet medical need. Approval uses surrogate endpoints likely to predict clinical benefit.

In oncology, common surrogate endpoints include:

• Objective Response Rate (ORR): The proportion of patients with tumor size reduction
• Progression-Free Survival (PFS): Time from treatment initiation to disease progression or death
• Disease-Free Survival (DFS): Time after treatment when patient survives without disease signs

According to FDA briefing documents, oncology indications account for 60% of all accelerated approvals since 1992, rising to 76% of approvals granted since 2020. The program has expanded dramatically: 13 approvals during 1992-2001 compared to 125 during 2013-2022.

What Happens After FDA Accelerated Approval?

Drugs granted accelerated approval must run post-marketing confirmatory trials to verify clinical benefit. The period between accelerated approval and confirmatory trial completion creates risk. Patients receive treatments that may eventually fail to show benefit.

According to research published in eClinicalMedicine analyzing 167 accelerated approval oncology indications from 1992-2022:

Outcome	Number	Percentage
Converted to regular approval	102	61%
Withdrawn	31	19%
Pending verification	34	20%

The FDA data shows median time from accelerated approval to traditional approval is 3.1 years, while median time to withdrawal is 4.1 years. Approximately 5% of oncology accelerated approvals have been withdrawn for failure to confirm benefit.

Why Does the Regulatory Gap Matter for South African Patients?

The absence of accelerated approval mechanisms creates a two-tiered access scenario. South African oncology patients may wait 2-4 years longer than patients in markets with expedited pathways to access novel therapies demonstrating clinical benefit in international trials.

This delay forces difficult choices. Clinicians managing advanced cancers may lack access to treatments already standard-of-care in the United States, European Union, Australia, and Canada. Patients with financial means might pursue personal importation, compassionate use requests, or international medical travel. Most South Africans cannot access these options.

Pharmaceutical sponsors may also deprioritize South African submissions if regulatory requirements appear disproportionate to market size. The lack of a formal accelerated pathway creates uncertainty for companies contemplating registration, potentially reducing the number of innovative therapies available.

What Regional Developments Could Shift SAHPRA Policy?

Regulatory harmonization initiatives across Africa may create momentum for SAHPRA to adopt accelerated mechanisms. In February 2025, SAHPRA joined Ghana's FDA, Egypt's EDA, Tanzania's TMDA, and Ethiopia's EFDA in signing a Memorandum of Understanding facilitated by the Africa CDC and AUDA-NEPAD.

This landmark agreement aims to:

• Foster collaboration among WHO Maturity Level 3 National Regulatory Authorities
• Create frameworks for regulatory reliance and mutual recognition
• Streamline regulatory decisions to speed up medicine approvals
• Promote collaboration on vaccine lot releases
• Enable local production of medical products

The African Medicines Regulatory Harmonization (AMRH) program provides additional infrastructure for aligning regulatory standards. However, implementing accelerated approval would require SAHPRA to invest in enhanced pharmacovigilance systems capable of intensive post-marketing monitoring.

What Barriers Block SAHPRA Accelerated Approval Adoption?

Several factors explain SAHPRA's cautious stance. Limited resources may restrict capacity for faster reviews and post-marketing surveillance. SAHPRA may hesitate to rely on international surrogate endpoint data without South African validation.

Stakeholder consensus also matters. The South African healthcare context includes competing priorities beyond oncology—HIV/AIDS, tuberculosis, and maternal health all demand attention. Expensive novel cancer therapies approved via accelerated pathways could raise equity concerns if public healthcare systems cannot distribute them broadly.

The 2022 Food and Drug Omnibus Reform Act (FDORA) strengthened FDA authority to require confirmatory trials be well underway at accelerated approval time, mandate 180-day progress reports, and expedite withdrawal when benefit is not verified. SAHPRA would need equivalent legislative frameworks to implement similar safeguards.

Frequently Asked Questions

Primary Sources

1. South African Health Products Regulatory Authority. Request for Priority Review of New Medicines and Type II Variation Applications. Version 3, December 2023.
2. U.S. Food and Drug Administration. Oncologic Drugs Advisory Committee Meeting Briefing Document: Timely Verification of Clinical Benefit After Accelerated Approval. November 16, 2023.
3. Bezerra CG, et al. Predictors of withdrawal of anticancer drug indications granted accelerated approval: a retrospective cohort study. eClinicalMedicine. 2025.
4. South African Health Products Regulatory Authority. Landmark agreement among Africa's leading National Medicines Regulatory Authorities to foster collaboration. February 5, 2025.
5. U.S. Food and Drug Administration. Accelerated Approval Program. Updated May 2026.