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- ICH Official web site : ICH
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 discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines
- ICH Official web site : ICH
ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years
- ICH Official web site : ICH
The Q3C ICH Guideline was finalised under Step 4 in July 1997, providing recommendations on the use of less toxic solvents in the manufacture of drug substances and dosage forms, and setting pharmaceutical limits for residual solvents (organic volatile impurities) in drug products Maintenance Process
- ICH HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3)
The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies
- ICH Official web site : 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 You can also download the information in a spreadsheet by clicking on
- ICH Official web site : ICH
The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics pharmacogenomics techniques to produce better targeted medicines
- ICH Official web site : ICH
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 an international association, a legal entity under Swiss law
- ICH Official web site : ICH
For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities The CTD is organised into five modules Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions
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