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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
This Guideline has been revised a second time and has reached Step 4 of the ICH process in February 2003 This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I and II
- ICH Official web site : ICH
The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories
- 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
- ICH Official web site : ICH
The ICH E11A Guideline reached Step 4 of the ICH process on 21 August 2024 The E11A Guideline provides recommendations and promotes international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines
- ICH Official web site : ICH
In order to facilitate the implementation of the CTD General (M4) Guideline, the ICH Experts have developed a series of Q As The document which reached Step 4 of the ICH Process in June 2004, intends to clarify the key issues regarding the CTD
- 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
- 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
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