title: Accelerating access to new medicines: Current status of facilitated regulatory pathways used by emerging regulatory authorities.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.Journal of Public Health Policy advance online publication, 10 March 2016; doi:10.1057/jphp.2016.8.
authors.affiliation: Centre for Innovation in Regulatory Science (CIRS), 77 Hatton Garden, London EC1N 8JS, UK.|Utrecht Institute for Pharmaceutical Sciences, Utrecht University 3584 CS Utrecht, The Netherlands.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Liberti
authors.affiliation: School of Life Sciences, University of Liverpool, Liverpool L69 7ZB, UK.
authors.forename: Alasdair
authors.initials: A
authors.lastname: Breckenridge
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Utrecht University 3584 CS Utrecht, The Netherlands.|Innovation Studies Group, Copernicus Institute for Sustainable Development, Utrecht University 3584 CS Utrecht, The Netherlands.
authors.forename: Jarno
authors.initials: J
authors.lastname: Hoekman
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Utrecht University 3584 CS Utrecht, The Netherlands.
authors.forename: Hubert
authors.initials: H
authors.lastname: Leufkens
authors.affiliation: The Bill and Melinda Gates Foundation, Seattle, WA 98109, USA.
authors.forename: Murray
authors.initials: M
authors.lastname: Lumpkin
authors.affiliation: Centre for Innovation in Regulatory Science (CIRS), 77 Hatton Garden, London EC1N 8JS, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: McAuslane
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Utrecht University 3584 CS Utrecht, The Netherlands.
authors.forename: Pieter
authors.initials: P
authors.lastname: Stolk
authors.affiliation: Temple University School of Pharmacy, Philadelphia, PA 19140, USA.
authors.forename: Kaining
authors.initials: K
authors.lastname: Zhi
authors.affiliation: The World Health Organization, Geneva 1211, Switzerland.
authors.forename: Lembit
authors.initials: L
authors.lastname: Rägo