Regulatory Blog

South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template

SAPHRA Guidance: Guideline On Co-Applicancy

South Africa (SAPHRA): Reliance Guideline

South Africa SAPHRA: Guideline For Professional Information For Human Medicines (Categories A and D) and Classification of Medical Devices and IVDs

South Africe SAPHRA: Guidelines For Medicine Recalls – Withdrawals And Rapid Alerts

South Africa's (SAPHRA): Import Applications Of Electronic Devices Emitting Ionizing Radiation

South Africa's (SAPHRA): Questions And Answers Licensing Of Medical Device Establishments

South Africa's (SAPHRA): Renewal Of Human Medicines Requirements and Process

South Africa's (SAPHRA): Guideline on Pharmacovigilance Systems

South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1

South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS

South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH

SAPHRA Guideline: Questions And Answers Licensing Of Medical Device Establishments

South Africa's (SAPHRA) Guideline for Fixed-Dose Combination Products

South Africe SAPHRA Guideline: For the API Master File (APIMF) Procedure

SAPHRA (ECTD & Human Medicines Unit): Variation Communication Guideline

SAPHRA - Guideline on Availability of Medicines for Use in a Public Health Emergency (PHE)

SAHPRA Guidance on Pharmacovigilance Inspections for Human Medicinal Product

South Africa (SAHPRA) Guidance on How to Submit Variation Applications

South Africa’s (SAHPRA’s) updated Reliance Guideline for a New Registration or Variation Application