Regulatory review process: What are enablers? Defined process and procedures Project management Adherence to target times Scientific decision making Competency of staff Role of experts Scientific consistency Good review practice Legal consistency Detailed guidelines Publication of summary basis of approval Actual timelines Application status tracked by sponsor Usefulness of published guidelines Dialogue Detailed summary basis of approval Alignment with International requirements Predictability Transparency Timeliness Quality Regulatory systems vary across countries as well as over time. However, the characteristics that reflect the activities of a well-developed regulatory agency are recognised through four attributes that are embedded into their process and procedures:  Transparency Timeliness Predictability Quality As shown in this illustration, each of these attributes encompasses several characteristics. Source: CIRS 2011 Emerging Markets focus study- Understanding the enablers of good regulatory process and decision making. What are the features that enable a transparent, timely, predictable and good-quality review?