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2 min read
The South African Health Products Regulatory Authority (SAHPRA) continues to refine its regulatory framework for medicinal products, with September 2025 bringing two significant updates. These updates emphasize labelling compliance and modernized dossier submission standards and SAHPRA eCTD guidelines, aligning South Africa more closely with international best practices.
Draft Guideline for Labelling of Medicines Intended for Human Use (SAHPGL-PEM-05 v1)
Published: 11 September 2025
This draft guideline establishes detailed requirements for the labelling of medicines in Categories A and D containing scheduled substances.
Key Highlights
- Mandatory Submission: Labels must form part of the registration dossier.
- Approval Requirement: Any changes to approved labels must be submitted to SAHPRA for authorization.
- Language Compliance: Labels must appear in English and at least one other official South African language, emphasizing multilingual labeling guidelines in South Africa.
- Packaging Scope: Both outer and inner packaging must carry compliant labels.
- Submission Format: Label files must be provided in Word and PDF formats, in line with SAHPRA eCTD guidelines.
- Accuracy Standards: Spelling, grammar, and technical accuracy will be closely scrutinized.
Impact: This signals a stronger focus on linguistic inclusivity, packaging transparency, and quality of information provided to patients and healthcare professionals. Companies must carefully review label design and translation processes to avoid delays in product approval.
Updated General Information Guideline (SAHPGL-HPA-07 v13)
Published: 8 September 2025
The updated general information guideline introduces structural and technical expectations for medicinal product registration in South Africa and amendment applications.
Key Highlights
- eCTD Transition: The electronic Common Technical Document (eCTD) format becomes mandatory for most human medicine applications (excluding complementary and veterinary medicines).
- Defined Roles: Responsibilities and signatures required from the Applicant, PHCR (Professional Head of Clinical Research), and HCR (Holder of Certificate of Registration) are clarified.
- Risk-Based Reviews: SAHPRA outlines full, abridged, verified, and priority review pathways, giving sponsors more flexibility depending on product type and data availability.
- GMP Expectations: Reinforces good manufacturing practice in South Africa, with emphasis on inspection readiness and compliance evidence.
- Lifecycle Management: Provides guidance for renewals, withdrawals, variations, and dossier submissions to streamline Regulatory oversight.
Impact: Sponsors need to strengthen electronic submission capabilities, ensure manufacturing sites comply with good manufacturing practices in South Africa, and strategically plan applications to leverage faster review pathways where eligible.
What This Means for Pharmaceutical Companies
The September 2025 updates underscore SAHPRA’s commitment to a more robust, efficient, and transparent Regulatory framework.
- Label Compliance: Companies must review existing labels and translation processes to meet the new multilingual requirements.
- Digital Transition: Moving to eCTD is no longer optional companies should invest in compliance tools and training now.
- Strategic Planning: Early identification of the appropriate review pathway (priority, abridged, verified, or full) can significantly shorten timelines.
- Operational Readiness: Ensure dossier quality and GMP documentation are audit-ready to avoid regulatory setbacks.
Your Next Step
Navigating the SAHPRA 2025 guidelines requires timely adaptation and proactive planning. By aligning your submission strategy for faster approvals with SAHPRA and these updates, you can accelerate approvals, ensure compliance, and gain a stronger foothold in the South African market.
Contact our Regulatory experts today to discuss how we can support your product submissions in line with SAHPRA’s latest requirements.
