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

7 February 2013

ICH M7 Guideline reaches Step 2 of the ICH Process

M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities...

20 December 2012

ICH E2C(R2) Guideline reaches Step 4 of the ICH Process

The purpose of this revised guidance is to ensure that the periodic safety update reports

20 December 2012

ICH S10 Guideline reaches Step 2 of the ICH Process

The ICH S10 Guideline on Photosafety Evaluation of Pharmaceuticals reached Step 2 of the ICH Process in November 2012 and now enters the consultation period (Step 3). This new Guideline on photosafety testing will be a valuable...

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.