1. 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: .
The CIRS Emerging Markets Workshop to be held in Beijing 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.