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The ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in December 2014 and now enters the implementation period (Step 5).
The SC agreed on the key issues relating to the reform of ICH in terms of governance, new membership and funding. ICH remains committed to enhanced communication, transparency and the openness of ICH to all relevant stakeholders.
The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Lisbon, Portugal, EU on November 8-13, 2014. The meeting was hosted by the European Commission and included over 300 participants.
ICH MedDRA Management Board Endorses Blue Ribbon Panel Recommendation for a 27th SOC.
A comprehensive report of the last ICH meeting that was held in Minneapolis, MN, USA on 4-5 June 2014 is now available on the ICH website under the SC Reports page.
During summer 2014, the ICH Steering Committee approved the establishment of four new ICH Efficacy Expert Working Groups.
Geneva, August 15, 2014 – ICH is conducting a Call for Tender for the MedDRA Maintenance and Support Services Organization (MSSO) contract.
The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 4 of the ICH Process and now enters the implementation period (Step 5).