A comprehensive study of underlying requirements to implement a globally applicable approach
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.
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.
A review of major guidelines and their advantages to patients and the healthcare community.
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.
A report of a Committee The committee that considered the opportunities that increased reliance activities by
regulatory authorities might provide to national and global public health while considering
the practical difficulties of implementing such reliance activities..
The results of this paper imply and confirm that a multidisciplinary approach must be taken in order to enhance the current global pharmaceutical regulatory process.
IFPMA Position paper on practical considerations regarding implementation of reliance
EFPIA Position paper on practical considerations regarding the effective use of reliance pathways
What are the barriers and facilitators?