18 June 2011

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Cincinnati, Ohio from June 11-16, 2011.

Global Outreach Activities

For the first time, non-ICH regulators have been nominated to serve as experts in some quality, safety and efficacy expert working groups (EWGs). ICH welcomed the active participation of technical experts from China, Chinese Taipei, Korea and Singapore.

In efforts to further the global reach of ICH, the Global Cooperation Group (GCG) accepted the request of the East African Community (EAC) to join the other Regional Harmonization Initiatives in the GCG dialogue. The EAC is comprised of five countries: Kenya, Uganda, Tanzania, Rwanda and Burundi. In recent years, the EAC’s work on harmonization of medicines regulation has increased, and with the support of the World Health Organization, they have moved towards implementing many ICH guidelines, including the ICH Common Technical Document (CTD).

A group of global regulators who are cooperating in the area of cell therapy updated the ICH Steering Committee on their activities and reported that they are exploring potential areas for future harmonization or other approaches to regulatory convergence.

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