22 November 2012

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in San Diego, California, USA on November 10-15, 2012. Building on the new principles of governance defined in Fukuoka, Japan in June 2012, the ICH SC approved procedural changes that reflect these principles. The ICH SC discussed further reform aimed at increasing the engagement of regulators globally and reiterated its commitment to the importance of harmonisation. Further progress was made on the individual topics, notably the safety reporting Guidelines E2B(R3) and E2C(R2) reached Step 4.

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