International Conference on Harmonization: Recent Reforms as a Driver of Global Regulatory Harmonization and Innovation in Medical Products.

Abstract

Eight years ago, this journal published "The Value and Benefits of the International Conference on Harmonization to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health" to mark the 20th anniversary of the International Council on Harmonization (ICH). Much has happened since following the reform of ICH, which culminated in 2015 with the establishment of ICH as an international nonprofit association. This entailed a transformation of the collaboration between a limited number of parties in an informal setting into a formal international organization with its own legal entity. The reform was a time-consuming exercise preceded by in-depth and complex discussions, where different options had to be considered and different interests balanced while ICH continued its normal harmonization work within the existing framework. However, the mission of ICH remained unchanged: advancing harmonization for better health. This article describes what triggered the reform and the work that paved the way for reaching the end result.