A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways

Area of Science:

• Regulatory Science
• Pharmaceutical Policy
• Global Health

Background:

• Regulatory agencies face pressure to expedite reviews for critical medicines to ensure equitable access.
• Facilitated Regulatory Pathways (FRPs) offer strategies to accelerate medicine assessments.
• Lack of formal guidelines and consensus hinders the optimal use of FRPs by regulatory authorities.

Purpose of the Study:

• To present a pragmatic 4-step framework to guide regulatory agencies in effectively utilizing FRPs.
• To establish a structured approach for selecting and implementing appropriate FRPs.
• To address the multifaceted considerations for the successful application of FRPs.

Main Methods:

• A 4-step pragmatic approach was developed based on research, surveys, literature reviews, and practical experience.
• The framework incorporates assessment of environmental preparedness, process criteria, agency capacity, and FRP selection.
• Target timelines for FRP implementation are proposed within the framework.

Main Results:

• Step 1 assesses environmental preparedness across four domains.
• Step 2 outlines essential process criteria for effective FRP utilization.
• Steps 3 and 4 guide agencies through self-assessment and selection of the most relevant FRP, including proposed timelines.

Conclusions:

• The proposed framework is the first comprehensive approach to holistically address the effective use of FRPs.
• This structured methodology supports regulatory agencies in optimizing the use of expedited review pathways.
• Implementation of this framework can enhance timely access to essential medicines globally.