Resources

Comparing Regional Regulatory Initiatives

 The three main approaches that have been used to date are illustrated in this graphic.   Used by permission from the Centre for Innovation in Regulatory Science (CIRS). 

Globally Applicable Facilitated Regulatory Pathways to Improve Equitable Access to Medicines

A comprehensive  study of underlying requirements to implement a globally applicable approach

Regulatory Frameworks in Times of Uncertainty

 Patient and public expectations on access to new types of medicines has changed the role of the regulator in granting marketing authorizations. Whether current regulatory frameworks can accommodate further advances in biomedical science remains a challenge, but suggestions are made as to how this may be possible. 

A Proposed Framework for a Globally Applicable Pragmatic Approach to Using FRPs

 Despite their availability, there are no formal guidelines or consensus for the definition, basic elements, or best practices for FRPs.  Herein, we present a 4-step pragmatic approach to a framework designed to help agencies determine how best to use FRPs. 

FDA's Expedited Programs and their impact on the availability of new therapies

A review of major guidelines and their advantages to patients and the healthcare community. 

FDA Facilitated Regulatory Pathways: visualizing their characteristics, ....

The authors sought to determine to what extent the combination of two or more FRPs influenced development and approval times. They developed a “metro map” to illustrate FRP elements and their influence on review times.