Figure 2.

The Proposed Improved Regulatory Review Model for the SAHPRA. Abbreviations: BR, benefit-risk; EDMS, electronic document management system; FRP, facilitated regulatory pathway; GBT, global benchmarking tool; GRP, good regulatory practice; GRevP, good review practice; GRelP; good reliance practice; MA, marketing authorisation; RS, regulatory system; SAHPRA, South African Health Products Regulatory Authority; SOPs, standard operating procedures; QMS, quality management system; UMBRA, Universal Methodology for Benefit-Risk Assessment; WHO, World Health Organization; ZAPAR, South African Public Assessment Report.