What Is Regulatory Approval for Human and Veterinary medicines in South Africa? A Technical Deep Dive Into Frameworks, Challenges & Emerging Trends

1. What Is Regulatory Approval?

Regulatory approval in South Africa refers to the scientific and administrative process administered by the South African Health Products Regulatory Authority (SAHPRA), under the Medicines and Related Substances Act 101 of 1965. It ensures that human/veterinary medicinal products entering the market satisfy the three core pillars of quality, safety, and efficacy.

• Applicants must compile a dossier in CTD/eCTD format (Modules 1–5), adhering to SAHPRA’s regional specifications.
• Registration creates legal authority for marketing, distribution, and post-market activities (labeling, pharmacovigilance, batch-release) in South Africa.

2. What Is the Regulatory Framework for Medicine Approvals?

2.1 Submission Formats & Technical Dossier

The SAHPRA guideline “Guidance for the Submission of the South African CTD-eCTD – General & Module” (Doc 2.24 v6) outlines the structure and expectations of the dossier.

• Module 1 (administrative/local information) is region-specific and essential for SAHPRA review.
• SAHPRA now mandates the use of the eCTD portal for submissions.
• The Reliance Guideline (SAHPGL-BAU-01, 2025) sets out abridged and recognition pathways leveraging trusted reference regulators.

2.2 Review Pathways

• Full Review: Traditional path for new chemical entities (NCEs), novel biologics, and first-in-country submissions.
• Abridged/Recognition/Reliance: SAHPRA may rely on prior approval by recognised regulators (US FDA, EMA, TGA, Health Canada) to reduce review burden.
• Conditional/Section 21 Access: For unregistered medicines under exceptional circumstances, public-health emergencies, or named-patient access.

2.3 Post-Approval and Lifecycle Management

• SAHPRA’s Risk Management Plan (RMP) Guideline (SAHPGL-CEM-PV-03) sets expectations for pharmacovigilance, safety updates, and periodic review.
• Variations and renewals are governed by SAHPRA guidelines (SAHPGL-HPA-06) and the general information guideline.

3. What Are the Current Challenges?

• Review backlog & inconsistent timelines: Despite efforts to clear backlogs, full-review pathway timelines may stretch up to 48 months for complex dossiers.
• Submission quality: Poorly formatted or incomplete dossiers often lead to review delays, emphasising the importance of consistent CTD structure and regional Module 1 compliance.
• Harmonisation vs local adaptation: Although SAHPRA aligns with ICH standards, local requirements (labeling, language, public-health priorities) remain. Applicants must navigate both global and national norms.
• Inspection and GMP capacity: Manufacturing-site inspections, especially for imported products, are still a bottleneck in many cases.
• Emerging product types: Advanced therapies (gene, cell, tissue), AI/ML-enabled devices, and biosimilars pose Regulatory complexity in a framework still adapting.

4. What Are the Emerging Trends?

• Digitisation & eCTD adoption: SAHPRA’s eCTD portal supports validation criteria, full traceability, and lifecycle management (sequence submissions).
• Regulatory reliance and regional collaboration: Use of reliance pathways and participation in initiatives such as the ZaZiBoNa Collaborative Medicines Registration Programme and the African Medicines Agency (AMA) are increasing efficiency across Africa.
• Stronger vigilance & RMP expectations: SAHPRA emphasises proactive risk-management and integrated safety surveillance post-registration.
• Expansion of advanced-therapy regulation: With biologics, biosimilars, and cell/gene therapies growing, SAHPRA is adapting guidelines and leveraging international reference frameworks.

5. What Should Sponsors Focus On Technically?

• Dossier-format integrity: Ensure CTD Modules 1–5 is complete, logically structured, with robust Module 2 summaries drawing from Modules 3–5. Use SAHPRA’s eCTD validation criteria.
• Data bridging & reliance justification: If leveraging a reliance pathway, you must clearly map foreign authority approvals, justify differences, and demonstrate comparability.
• Local agent/MAH governance: The authorised person/local MAH must be registered in South Africa and listed in the dossier (Module 1).
• Manufacturing site readiness: GMP certificate, site master files, validation data, and inspection history must satisfy SAHPRA’s GMP guideline (SAHPGL-INSP-02) and inspection readiness expectations.
• Lifecycle infrastructure: Ensure you have a pharmacovigilance system master file (PSMF), RMP, variation strategy, and renewal calendar to manage the full product lifecycle.

Ready to navigate SAHPRA’s advanced Regulatory landscape with certainty and technical precision?Contact our Regulatory experts today to build a tailored strategy, optimise your CTD/eCTD dossier, and secure compliant, efficient market access in South Africa.