ICH published a summary of its November meeting in North Carolina, USA. The summary: ● highlights progress on new and
existing ICH guidelines ● describes training as a key to successful implementation, and ● notes the importance of understanding
the level of members’ implementation of ICH guidelines. It was the first face-to-face meeting of ICH’s expanded Management
Committee, including representatives from the agencies of Singapore, Korea, and China and from the associations BIO and IGBA.
ICH now has 16 members and 28 observers. Iran’s regulatory agency was approved as an observer by the Assembly at the
meeting. [See IPQ September 6, 2018 for an an in-depth review of how ICH is evolving.]