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 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 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 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
Overview of ICH ICH has achieved international harmonisation of technical guidelines, with engagement of regulators and industry ICH has clear governance and increasingly global membership following ICH reform Five transparent steps in the ICH process for Guideline development Summary
ICH Official web site : ICH The ICH E6(R3) “Good Clinical Practice” Guideline provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities The guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies