- ICH Official web site : ICH
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 members, 41 observers, and a network of close to 700 experts globally
- ICH Official web site : ICH
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 Regulatory Genotoxicity Tests for Pharmaceuticals was finalised under Step 4 in July 1995
- STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS
At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures
- Harmonisation for better health | ICH
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss the scientific and technical aspects of pharmaceutical development
- ICH Official web site : ICH
Information on the status of implementation of ICH Guidelines by ICH Regulatory Members can be searched via the table below Please select the relevant topic, Guideline and or ICH Member to consult the status, date of implementation, as well as to access the reference
- ICH Official web site : ICH
Both of these Guidelines are related to ICH’s harmonised electronic standards work, which is advanced by ICH Expert Working Groups and also through joint initiatives with other standards development organisations to ensure global interoperability
- Quality Guidelines - ICH
Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management
- Search the Index of ICH Guidelines | ICH
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 Please select first the relevant topic You can then search by ICH Step status, date, and or by keyword
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