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You will find in this section the recent latest new from the ICH.
Steering Committee revises the S1 Strategy
In November 2012, the SC endorsed the revision of both the S1 Concept Paper and Business Plan to provide clarification concerning how the prospective data gathering period should be integrated in the normal ICH Step process.
Press release from the ICH Steering Committee meeting in San Diego, 14-15 November 2012
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...
Press release from the MedDRA Management Board meeting in San Diego, 10-11 November 2012
The Board is pleased to announce that, for the eighth year in a row, there will be no increase in MedDRA subscription rates for 2013. This is the result of continued growth of MedDRA subscribers throughout the world and increased...
Draft ICH eCTD Implementation Guide undergoing Step 2 for Testing
In October 2012, the Draft eCTD Implementation Guide (v0.1) was released under Step 2 for Testing to give an opportunity to stakeholders to conduct testing to confirm its technical feasibility.