The aim of this Briefing is to review and summarise the findings from the major studies and interactions carried out by CIRS in LATAM in the last decade in order to describe the changes to the regulatory landscape, focusing on the following topics:

  • The alignment of regulatory procedures in the region of Latin America
  • Changes in regulatory review times
  • The extent to which good review practices are embedded in the agencies
  • Recommendations and learnings from the 2014 CIRS Workshop in Lima
  • Recent observations and insights from agencies and companies based in Colombia, Brazil and Mexico

This Briefing is intended as a background document to encourage discussion among and between regulatory agencies and companies of the outlined key issues, and to promote further improvements to the LATAM regulatory landscape.