South Africa's SAHPRA: Communication to Industry on Quality Variations
South Africa-SAHPRA: Engagement Portal
SAPHRA News: Implementation of RIMS – Information on eCTD 3.1 Module 1
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)