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South Africa SAHPRA’s Guidelines: Section 21 Access to Unregistered Medicines and Quality & Bioequivalence Requirements
On 23rd October 2025, the South African Health Products Regulatory Authority (SAHPRA) continues to strengthen its regulatory framework to ensure that all medicines—whether registered, imported, or accessed under exceptional circumstances—meet the highest standards of safety, quality, and efficacy. Two of SAHPRA’s most recent guidance documents, namely the Guideline for Section 21 Access to Unregistered Medicines and the Quality and Bioequivalence Guideline , play a pivotal r
Sharan Murugan
Nov 1, 20252 min read
SAHPRA Guideline: Section 21 Access to Unregistered Medicines
The South African Health Products Regulatory Authority (SAHPRA) has updated its Guideline " Section 21 Access to Unregistered Medicines "...
Sharan Murugan
Apr 6, 20253 min read