China has made significant changes to its medicine regulatory system including:

  • Regulatory reforms – since 2015, regulatory reforms have helped to eliminate application backlogs, improve review timelines and increase approvals of innovative drugs.
  • ICH – Involvement with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), first as a regulatory member in 2017 and then joining the Management Committee in 2018, has promoted alignment with international standards and enhanced exchange and cooperation with other regulatory and industry members.
  • Expedited pathways – Breakthrough, conditional, priority and special review pathways introduced in 2020 are supporting accelerated development and approval of drugs with significant clinical value or for urgent health needs.

But what do companies think of these changes?

This R&D Briefing summarises the findings of a study that examined CIRS member companies’ perceptions of the evolving regulatory landscape in China, with the aim to identify current challenges and opportunities for improvement.