You will find in this section the recent latest new from the ICH.

4 December 2012

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.

22 November 2012

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...

11 November 2012

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...

23 October 2012

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.