South Africa: SAHPRA Revises GCP Training Requirements and Issues Clinical Trial Application Guidance for Public Health Emergencies

April 16, 2020

On April 13, 2020, the South African Health Products Regulatory Authority (SAHPRA) issued GCP Training and Expedited Review of Clinical Trial Applications during COVID-19 Pandemic. The notice states that SAHPRA has amended requirements for in-person good clinical practice (GCP) training to allow for online training during the COVID-19 pandemic. The notice also states that SAHPRA is committed to reviewing COVID-19 clinical trial applications within 7 to 10 working days and refers applicants to the newly released Application to Conduct a Clinical Trial: Guidance in Conditions of a Public Health Emergency.