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. It includes the ich medical terminology (meddra), the common technical document (ctd) and the development of electronic standards for the transfer of regulatory information (estri). The ich harmonised guideline was finalised under step 4 in february 2002.
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,. 330 cqas should be identified using the principles outlined in ich q6a, q6b and ich q8-q11.
About ich mission history transparency funding ich award work with ich articles & procedures work plans & reports organisational chart members & observers value of membership application. The ich harmonised guideline was finalised under step 4 in november 2011. It replaces and combines the ich s2a and s2b guidelines.
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. 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. May 6, 2025to download the updated ich q5a (r2) training modules, please see the q5a (r2) iwg webpage on the ich website.
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