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Resources
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.
Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators (2019).
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 DISARRAY IN THE REGULATORY APPROVAL PROCESS FOR INTRODUCING NEW MEDICINES TO PATIENTS (2014)
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.
Considerations for effective regulatory reliance – an Industry perspective (2019)
IFPMA Position paper on practical considerations regarding implementation of reliance
White paper on reliance and expedited registration pathways in emerging markets (2017)
EFPIA Position paper on practical considerations regarding the effective use of reliance pathways
INTEGRATING PHARMACEUTICAL SYSTEMS STRENGTHENING IN THE CURRENT GLOBAL HEALTH SCENARIO (2020)
What are the barriers and facilitators?