Enablers of an effective regulatory review Timeliness is enabled by Predictability is Transparency is Quality is enabled by adherence to target timelines during review detailed guidelines a detailed summary of approval agencies’ adherence to international standards for requirements availability of different assessment routes and priority review requests meetings during development a detailed description of process the ability to negotiate patient information leaflet label defined and efficient processes pre-NDA meetings published decision frameworks internal training dedicated project management the ability to track progress of an application published approval times the ability to negotiate and the ability of regulators to give approval with the provision of providing a post-approval commitment detailed target times the ability to contact agency personnel consistent review assessment methods the ability to conduct a dialogue with an assessor for clarification of issues raised in a deficiency letter In 2011, CIRS conducted a study to identify the regulatory practices, processes and procedures that would enable the timely, predictable, transparent and good-quality review of new medicines. The findings from this study were presented at a CIRS annual Emerging Markets Workshop in December 2011 held in Kuala Lumpur, entitled Evolving the regulatory review process: What are the features that enable a transparent, timely, predictable and good-quality review? As presented at that Workshop, this table lists some of the results of this survey: the attributes that were indicated by companies as extremely valuable enablers of timeliness, predictability, transparency or quality in a regulatory review. The full report of the CIRS Workshop in Kuala Lumpur is available on the CIRS website: http://www.cirsci.org/system/files/private/CIRS_December_2011_WS_Report.pdf . The CIRS Emerging Markets Workshop to be held in Beijing 23-24 January 2013, Regulatory review – How do agencies ensure the quality of the decision? will specifically examine the role of decision frameworks in the review of new medicines and the challenges and solutions that can facilitate agencies’ quality decisions.