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 – The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is conducting a Call for Tender for the MedDRA Maintenance and Support Services Organization (MSSO) contract.

Summary PAR - Generics (March 2018)

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 in November 2013 and now enters the implementation period (Step 5).

Summary PAR for non-generics (June 2014)

The SC is pleased to announce the decision that Heath Canada (HC) and Swissmedic are now Steering Committee members.

The Steering Committee will meet in Minneapolis, MN, USA from May 31 to June 5 to discuss ongoing harmonisation activities.

In March 2014, the ICH E2C(R2) Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers addressing new concepts and principles linked to an evolution of the traditional PSUR from an interval safety report to cumulative benefit-risk report and with a change in focus from individual case reports [...]

In March 2014, the ICH E14 Implementation Working Group (IWG) finalised under Step 4 of the ICH Process four additional Questions and Answers addressing Concentration-Response Relationships, Combination Products, Large Targeted Proteins and Monoclonal Antibodies and Special Cases.