ICH Moves Into Regulatory Communications

meeting in Brussels on October 26-27, exactly a year after the Second International Conference on Harmonization in Florida, the ICH Steering Committee has said it will extend its work on harmonization into the field of regulatory communication. The meeting included over 200 experts from the regulatory agencies and industry in the European Union, Japan and the USA to advise the Steering Committee, which also recommended the following harmonized tripartite guidelines as final:

- the extent of population exposure to assess clinical safety: guidance on numbers of subjects and duration required to assess safety through clinical trial programs;

- clinical safety data management - definitions and standards for expedited reporting: harmonization of key elements necessary for international reporting of adverse drug reactions;