Founded 35 years ago and registered as a non-profit legal entity under Swiss law in 2015, ICH has finalised nearly 80 Guidelines that are applied by regulatory authorities around the world. ICH has 25 …

The ICH Harmonised Guideline was finalised under Step 4 in February 2002. This document is intended to address recommendations on the application of bracketing and matrixing to stability studies …

The ICH Harmonised Guideline was finalised under Step 4 in November 2003. This document provides a standardised procedure for post-approval safety data management and the guidance for gathering …

The ICH Harmonised Guideline was finalised under Step 4 in November 2011. It replaces and combines the ICH S2A and S2B Guidelines. The S2A Guideline on Guidance on Specific Aspects of …

You can explore in the below table the index of all ICH Guidelines, finalised or under development, on the topics of Quality, Safety, Efficacy and Multidisciplinary.

The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural Assembly meetings on 23 October 2015 establishing ICH as …

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to …

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330 CQAs should be identified using the principles outlined in ICH Q6A, Q6B and ICH Q8-Q11. When 331 designing a stability protocol in support of a drug substance or drug product, information on the …