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3 min read
Navigating the regulatory landscape for medicinal products in South Africa requires expertise, as compliance with SAHPRA (South African Health Products Regulatory Authority) is mandatory for market access. Below, we address the top 10 frequently asked questions regarding pharmaceutical regulatory affairs, drug registration, and medical device compliance in South Africa.
1. What is SAHPRA?
South African Health Products Regulatory Authority (SAHPRA) is an independent Regulatory authority under the Department of Health that replaced the Medicines Control Council in 2018. It oversees the registration, licensing, post-market surveillance, clinical trial approvals, and pharmacovigilance of health products, including medicines, medical devices, and diagnostics. SAHPRA ensures compliance with international regulatory standards and Good Manufacturing Practices (GMP) to safeguard public health.
2. How do I register a new medicine in South Africa?
Registration involves classifying the product (e.g., new chemical entity, generic, biologic) and selecting a review pathway (Full, Reliance, Priority). Applicants must appoint a local Holder of Certificate of Registration (HCR). The submission follows an eCTD format with South Africa-specific Module 1, including clinical, quality (CMC), and nonclinical data aligned with ICH guidelines. Generics require bioequivalence data. SAHPRA evaluates dossier quality, safety, and efficacy before granting marketing authorization.
3. What are the requirements for clinical trials?
For clinical trials, requirements include:
- Application via CTF1 form, protocol, Investigator’s Brochure, informed consent forms, and ethics approval.
- Investigators must be qualified, registered with relevant statutory councils, and reside in South Africa.
- All sites must comply with Good Clinical Practice (GCP) and ensure participant insurance.
- Trials must be registered on the South African National Clinical Trials Register. SAHPRA and the National Health Research Ethics Council (NHREC) oversee compliance with legal, scientific, and ethical standards.
4. Are there fees for Regulatory submissions?
Yes. Fees for submissions (including new applications, clinical trials, variations, amendments, and licensing) are detailed in the Government Gazette and SAHPRA’s website. For 2025, new registrations, variations, and retention are subject to a published fee schedule. Examples: Application for new medicine registration: R1,900; clinical trial application (safety/efficacy): R33,700 (Regulations Regarding Fees, 2025).
5. How can I obtain a manufacturing or import license?
An application for a manufacturer’s or importer’s license must be submitted to SAHPRA, using the standard forms available on the SAHPRA website. Applicants must:
- Pay the prescribed fee,
- Provide proof of compliance with SA Guide to GMP, and
- Submit documentation on facility, pharmacy council registration, and zoning certificates. Licenses are valid for 5 years and are required for both local and foreign manufacturers importing into South Africa.
6. What is the process for post-registration variations?
All variations to registered products must be submitted according to the SAHPRA Variations Addendum, categorized as Type IA (minor), IB (moderate), or Type II (major). Each variation type has documentation and administrative requirements, and applicants may use the Digital Variations Portal. No variations are allowed during product renewal; separate submissions are required.
7. How does SAHPRA monitor adverse drug reactions (pharmacovigilance)?
SAHPRA has a national pharmacovigilance program involving:
- Mandatory reporting by holders of certificates of registration (HCRs) and healthcare practitioners for suspected adverse drug reactions (ADRs) and quality issues,
- Utilization of the Med Safety App for digital ADR/AEFI reporting,
- Collection of reports in VigiFlow® and uploading to VigiBase® (WHO UMC database),
Causality assessment and signal detection by SAHPRA’s Pharmacovigilance Unit and Advisory Committee.
8. Can unregistered medicines be imported for personal use?
Yes, but only with prior authorization from SAHPRA under Section 21 of the Act. The process requires an application by a healthcare professional, including justification, patient need, and details of the product. Only products with valid authorizations may be cleared for importation (usually limited to individual “named patient” circumstances)
9. How are generic medicinal products registered?
SAHPRA requires bioequivalence data, CMC documentation, stability studies, and labeling to ensure generics meet the same quality, safety, and efficacy as the reference medicine.
10. Where can I find more information on Regulatory affairs?
Key resources include:
- The SAHPRA website (www.sahpra.org.za): guidelines, regulations, contact points, fees, forms, policies, and updates,
- SAHPRA’s eCTD portal for technical submissions (eCTD Resources),
- Published guidelines such as the “General Information Guideline” (September 2025),
- Regulatory newsletters (ReguLetter), directory of OTC products, and rapid alerts.
Conclusion
Navigating South Africa’s regulatory environment is complex, partnering with an expert Regulatory affairs service can streamline approvals, ensure compliance, and accelerate market access.
Freyr Solutions provides end-to-end regulatory support in South Africa, from dossier preparation and SAHPRA submissions to post-marketing compliance and pharmacovigilance management.
Contact Freyr today to simplify your regulatory strategy in South Africa.
