Abstract
Objectives: We assessed the characteristics of currently implemented expedited (facilitated) regulatory pathways (FRPs) used by national regulatory authorities (NRAs) in emerging economies to speed access to important new medicines. Methods: We identified NRAs with FRPs through Thomson Reuters Cortellis Regulatory Intelligence and through agency Websites. We developed a list of 27 FRP characteristics. We categorised characteristics as procedural or substantive and based them on five sequential regulatory activities. Findings: We assessed 29 countries with 33 FRPs. The regions with the characteristics described most extensively by their FRPs were the Middle East/North Africa and Eastern Europe. The Sub-Saharan African region included the FRPs that were least specific in describing characteristics. Overall, FRPs presented at least twice as many procedural as substantive characteristics. Conclusions: We observed diversity by region in FRP characteristics, suggesting a role for further engagement with emerging NRAs in their design and implementation. Common processes could advance regulatory alignment initiatives and help the WHO inform the development of novel, globally aligned accelerated development and regulatory pathways for products that fulfil serious unmet public health needs.
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The authors wish to acknowledge the contributions of colleagues from regulatory agencies, pharmaceutical companies and consultancies who reviewed our interpretations of the characteristics of FRPs derived from the public domain.
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Liberti, L., Breckenridge, A., Hoekman, J. et al. Accelerating access to new medicines: Current status of facilitated regulatory pathways used by emerging regulatory authorities. J Public Health Pol 37, 315–333 (2016). https://doi.org/10.1057/jphp.2016.8
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DOI: https://doi.org/10.1057/jphp.2016.8