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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.
Quality Guidelines. 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.
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.
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.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public ...
Promotion of public health through international harmonisation that contributes to: Prevention of unnecessary duplication of clinical trials and post market clinical evaluations. Development and manufacturing of new medicines. Registration and supervision of new medicines.
1. ICH E6 Principles. (Draft Version: March 2021) Clinical trials are a fundamental part of clinical research that support the development of new medicines or uses of existing medicines. Well designed and conducted clinical trials help answer key questions in health care and drug development.
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 HARMONISED GUIDELINE. ANALYTICAL PROCEDURE DEVELOPMENT Q14. Final Version Adopted on 1 November 2023 . This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process.
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. Title.
