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. The ich harmonised guideline was finalised under step 4 in february 2002. 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 november 2003. Jun 15, 2016in 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.
The ich s5 (r3) provides human safety assurance at least equivalent to that provided by current testing paradigms. In addition, this revision intends to provide greater clarity and alignment with other 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.
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 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. 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.
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