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1 min read
Introduction
In the rapidly evolving South African pharmaceutical sector, understanding the medicinal product Regulatory framework is key to successful market access. The South African Health Products Regulatory Authority (SAHPRA) governs the registration of human medicines, ensuring they meet global standards of quality, safety, and efficacy. This guide is designed for Regulatory affairs professionals navigating the drug approval process in South Africa, offering a structured roadmap from pre-submission to post-market compliance.
1. Core Regulatory Pathways in South Africa
- New drug registration & CTD/eCTD submission: SAHPRA requires dossier submission under the CTD format for human medicines, with emphasis on Modules 1–5.
- Clinical trial authorisation: Before MAH submission, clinical trial applications must be approved.
- Variations and lifecycle management: Post-approval changes, renewals, and vigilance obligations are integral to staying compliant.
- Reliance and risk-based approaches: SAHPRA is increasingly exploring abridged review models and reliance on recognized regulators.
2. Step-by-Step Regulatory Journey for Medicinal Products
Step 1 – Classification & Pre-Submission
- Confirm product category: Innovative drug, generic, biosimilar, etc.
- Arrange a pre-submission meeting with SAHPRA to determine the correct Regulatory pathway.
Step 2 – Dossier Preparation (CTD/eCTD)
- Module 1: Local administrative information, MAH details, GMP certificates.
- Modules 2–5: Quality (CMC), non-clinical, clinical data aligned with global standards.
Step 3 – Submission & Review
- Use SAHPRA’s portal to submit dossier; ensure tracking of review progress and queries.
- Be prepared for GMP inspections and sample testing requests.
Step 4 – Post-Approval Compliance
- Set up pharmacovigilance (PV) systems, variation management, renewals, and maintain compliance with SAHPRA’s quality-management system references.
3. Key Challenges for Regulatory Affairs Professionals
- Longer timelines for review: Despite improvements, some full reviews still face delays.
- Submission quality issues: Poor dossier quality often causes extensive queries and delays.
- Digital readiness: Transition to eCTD and improved electronic submission systems are underway, requiring organisational readiness.
- Balancing global/regional alignment: While aligning with ICH standards, local South Africa-specific requirements (MAH, language, labeling) must be met.
4. Emerging Trends in the South African Pharmaceutical Market
- Accelerated adoption of eCTD submissions and digital dossier systems.
- Growing emphasis on Regulatory reliance models, leveraging recognised reference authorities to streamline review.
- Enhanced post-market surveillance and lifecycle management, improving long-term compliance and product quality.
- Strategic positioning of South Africa as a hub for regional access in Africa.
Looking to streamline your medicinal product registration in South Africa?
Connect with Freyr’s Regulatory affairs experts who specialise in SAHPRA submissions, CTD/eCTD readiness, and lifecycle compliance.
Contact us here.
