A study published in the July 2018 issue of Therapeutic Innovation & Regulatory Science (TIRS) evaluates the current South African regulatory review process within the MCC, identifying regulatory milestones and review times prior to the establishment of the new South Africa Health Products Regulatory Authority (SAHPRA). Sam Salek, Professor of Pharmacoepidemiology at the School of Life and Medical Sciences, University of Hertfordshire, UK, and co-author of the study discusses the main findings as well as the challenges and opportunities for enhanced regulatory practices in South Africa.