The South African Health Products Regulatory Authority (SAHPRA) continues to advance its digital transformation agenda with the SAHPRA Engagement Portal—a comprehensive platform designed to streamline Regulatory processes and stakeholder communication. Launched on April 1, 2025, as part of SAHPRA’s modernisation strategy, the portal significantly improves transparency, efficiency, and compliance in the handling of medicines and South Africa pharmaceutical regulations.Key Features of the Engagement PortalThe Engagement Portal is a secure, centralized interface for applicants and license holders. Its core functionalities include:Application Management: Submit and monitor product registrations, renewals, variation applications, and Section 21 SAHPRA authorizations.Document Handling: Upload, store, and access Regulatory documents securely.Real-Time Communication: View inspection notices, receive updates, and respond to SAHPRA online submission queries.Audit Trails: Full tracking of interactions and submissions for compliance and internal auditing.Latest Updates in 2025As of April 2025, SAHPRA introduced several key enhancements based on industry feedback and global best practices:Section 21 Checklist & Fee Revision: A new checklist simplifies Named and Multi-Patient applications. Pricing for multi-patient applications is now standardized at R400 per application for certain conditions, with others remaining at R400 per patient.New Export Application Tab: Applicants can now update and complete existing Health Product Applications (HPA), streamlining corrections and data validation.ICD-11 Integration: Indication fields now support multiple entries based on WHO's ICD-11 codes, aligning submissions with international standards.Flexible Strength Inputs: Users may now input dosages with either a comma or decimal point (e.g., 0.5 mg or 0,5 mg), reducing submission errors.Why the Portal MattersThe Engagement Portal is a significant leap forward in digital Regulatory governance:Efficiency: Accelerates application turnaround times by reducing reliance on manual correspondence.Transparency: Stakeholders have real-time access to application statuses, inspection notifications, and feedback.Compliance: Built-in validation tools and audit trails reinforce Regulatory integrity and traceability.