1. 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 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?