South Africa Profile Updated in ClinRegs

With this South Africa update, the NIAID ClinRegs Team pays tribute and honors the memory of our friend and collaborator, Gita Ramjee, who passed away in March. Gita directed the South Africa Medical Research Council clinical trials unit in Durban for many years. She had a tremendous passion for HIV prevention and she cared deeply about addressing the disparities in HIV incidence in young women. With all that, she still found time and resources to support us in keeping ClinRegs’ South Africa profile accurate and up-to-date. We are grateful to have called her our friend and colleague and we cherish her memory.

The South Africa profile in ClinRegs now includes the following updates:

• A new South African Health Products Regulatory Authority (SAHPRA) website, including updated information on clinical trials
• Updated guidance and application forms for the clinical trial application submission and review processes (See Scope of Assessment, Submission Process, Submission Content, and Timeline of Review)
• New guidance for clinical trial applicants on requesting a consultation meeting with SAHPRA (See Submission Process and Timeline of Review)
• New clinical trial guidance and application requirements during a public health emergency (See Submission Process and Submission Content)
• Revised form to register an ethics committee with the National Health Research Ethics Council (See Authorizing Body)
• Updated guidance on safety reporting (See Safety Reporting)
• New guidance on liability insurance for clinical trials (See Insurance)