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The South African Health Products Regulatory Authority (SAHPRA) is the national Regulatory body responsible for overseeing the safety, efficacy, and quality of health products in South Africa. Functioning under the Department of Health, SAHPRA plays a crucial role in ensuring that all medicines, medical devices, and health-related products meet the standards necessary to protect public health.

Background and Formation

SAHPRA was established in February 2018, replacing the Medicines Control Council (MCC) and incorporating several functions from the Directorate of Radiation Control. The formation of SAHPRA marked a significant Regulatory transformation to strengthen health product oversight and align with global Regulatory standards.

Mandate and Responsibilities

SAHPRA’s core mandate is to regulate:

  • Medicines (allopathic, complementary, and herbal)
  • Biological products
  • Medical devices
  • In vitro diagnostics (IVDs)
  • Radiation-emitting devices
  • Clinical trials for investigational products

Its mission is to ensure that all health products available in South Africa are safe, effective, and of high quality—protecting the public while facilitating innovation and access to essential therapies.

Key Functions of SAHPRA

  1. Product Registration and Approval
    SAHPRA evaluates applications for new medicines and medical devices, ensuring that they comply with scientific, clinical, and Regulatory standards before granting marketing authorization.
  2. Licensing of Manufacturers and Importers
    Facilities involved in the manufacture, import, export, distribution, or sale of health products must be licensed by SAHPRA and comply with Good Manufacturing Practices (GMP).
  3. Clinical Trial Oversight
    Any clinical trial conducted in South Africa involving investigational products must be reviewed and approved by SAHPRA to ensure ethical standards and participant safety.
  4. Pharmacovigilance and Post-Market Surveillance
    SAHPRA monitors the safety of health products even after approval, including adverse event reporting and risk management.
  5. Radiation Control
    The authority regulates radiation-emitting medical equipment, ensuring its safe use and compliance with safety protocols.
  6. Import and Export Control
    Health products entering or leaving South Africa are subject to SAHPRA review and approval, particularly if not registered locally.

SAHPRA’s Regulatory Framework

SAHPRA operates under the following key legislative and policy frameworks:

  • Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)
  • Radiation Control legislation
  • National Health Act, 2003
  • Various guidelines and regulations are published periodically to align with global best practices (including those of the WHO, EMA, and FDA).

Recent Developments and Digitalization

In its ongoing effort to modernize, SAHPRA has introduced:

  • The SAHPRA e-Submission (eCTD) Portal, allowing fully electronic dossier submissions. This reflects SAHPRA’s shift into digital Regulatory systems in 2024–2025
  • Launch of the SAHPRA Engagement Portal (April 1, 2025), supporting interactive submissions, variations, and renewals—a key component of their Risk-Based Regulatory Review model.
  • Expanded post-market surveillance and pharmacovigilance, particularly for COVID-19 vaccines and high-risk products. SAHPRA continues proactive monitoring of adverse events and issuing safety updates to ensure ongoing product safety.

Why SAHPRA Matters for Life Sciences Companies

Complying with SAHPRA regulations is essential for pharmaceutical, biotech, and medical device companies to enter or operate in the South African market. From drug registration to clinical trial approval, SAHPRA’s authorization is mandatory.

Partnering with Regulatory experts like Freyr, who offer end-to-end support across SAHPRA submissions, dossier preparation, and compliance, can significantly streamline the approval process and accelerate market entry.

Conclusion

SAHPRA is at the forefront of regulating health products in South Africa, playing a pivotal role in public health protection and Regulatory modernization. With a strong mandate and an evolving digital infrastructure, SAHPRA is positioning itself as a globally respected Regulatory authority in the African region.