2 min read

When discussing pharmaceutical regulation in South Africa, most companies immediately think of SAHPRA (South African Health Products Regulatory Authority). While SAHPRA is the dedicated regulator for medicines, medical devices, and clinical trials, the National Department of Health (NDOH) plays an equally vital role in shaping the environment in which medicinal products are approved, distributed, and adopted.

The Role of NDOH in South Africa’s Healthcare and Pharmaceutical Ecosystem

The National Department of Health (NDOH) is the highest authority responsible for setting the strategic direction of South Africa’s health system. It provides the framework within which regulatory bodies like SAHPRA operate, ensuring that national health needs are met in a structured, equitable way.

From a pharmaceutical standpoint, the NDOH’s functions include:

  • Strategic Policy Direction: Defining national health priorities such as HIV/AIDS, tuberculosis, oncology, and maternal health, which influence the demand for medicines.
  • Formulary & Essential Medicines Management: Overseeing the Essential Medicines List (EML) and Standard Treatment Guidelines (STGs), which determine priority medicines for public sector use.
  • Procurement & Supply Chain Oversight: Managing bulk procurement and distribution of pharmaceuticals to ensure accessibility across all public health facilities.
  • Alignment with SAHPRA: Ensuring that medicines registered by SAHPRA also support South Africa’s broader public health objectives and fit within national health strategies.

In short, while SAHPRA regulates the entry of medicinal products, the NDOH ensures those products are aligned with national policies and made available to the population at scale.

NDOH and Medicinal Products: Key Intersections

  1. Essential Medicines List (EML):
    The NDOH maintains and updates the EML, guiding which medicines are considered essential and must be available nationwide. For pharma companies, inclusion on this list significantly improves uptake.
  2. Policy Alignment:
    Medicines addressing NDOH priorities—such as HIV, TB, or maternal health—are more likely to gain adoption in the public health system, making policy awareness a strategic advantage.
  3. Procurement and Access:
    Beyond SAHPRA registration, companies must engage with NDOH frameworks to be considered in national procurement programs, which enable large-scale distribution.
  4. Collaboration with SAHPRA:
    The NDOH and SAHPRA function in tandem: one safeguards public health through regulatory standards, while the other ensures medicines serve national healthcare goals.

Why This Matters for Pharma Companies

For sponsors, understanding the dual landscape—SAHPRA for regulatory clearance and NDOH for access and adoption—is crucial. Registration ensures compliance, but alignment with NDOH’s strategies ultimately drives market entry, scale, and sustainability in South Africa’s healthcare sector.

Conclusion

The NDOH and SAHPRA together form the backbone of South Africa’s healthcare system. SAHPRA guarantees that medicines are safe, effective, and high-quality, while the NDOH ensures they are aligned with policy, widely procured, and accessible. For companies planning to enter this market, both elements must be factored into a successful strategy.

Expand Your Reach in South Africa’s Pharma Market

Freyr’s Regulatory experts help pharmaceutical companies secure SAHPRA approvals while aligning with NDOH frameworks to ensure broader access and adoption.

Contact Freyr today to streamline your product registrations and market access in South Africa.