China moves on to ICH GCP, despite great challenges

China in June 2017 became a member of the e International Council for Harmonization (ICH), showing the world how determined it is to be a global player.In January, the China Food and Drug Administration (CFDA) announced it will gradually adopt ICH E2A, the guideline for clinical safety data management, by July 1, 2022, reports Wang Fangqing, The Pharma Letter’s local correspondent.

China’s current good clinical practice guideline was introduced in 2003, which was a drastically altered version of ICH E6 guideline. The Chinese GCP does not focus too much on safety.

This probably could explain why in 2016 China discovered over 80% clinical data from domestic companies was fabricated, and in May 2017 China’s supreme court recognized clinical data fabrication as a serious crime, which could lead to death sentence.