Using the Electronic Common Technical Document in Regulatory Filings

摘要

One of the major achievements of the International Conference on Harmonisation (ICH) has been the development of the common technical document (CTD), a standard structure for the dossier used when applying for marketing approval of a pharmaceutical product in the EU, the US and Japan. Once the CTD was established, the ICH began work on an electronic version, the eCTD, an interface for the transfer of information between industry and regulatory agencies.