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. 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,.
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. 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. In may 2005, an m5 consensus draft guideline containing ich business requirements for medicinal product identifiers, along with lists of controlled vocabularies for routes of administration and units of.
