Modules 2, 3, 4 and 5 are common for all regions. Module 1 contains administrative regional information which is differ for each country. The CTD is a format/structure for Modules 1 through 5 of the NDA (New Drug Application), MAA (Marketing Authorization Application), and global medicinal applications. In 2003, the members of ICH (International Council of Harmonization) have agreed to assembly all quality, safety and efficacy information in a common format which used to be called CTD. Since the information submitted in paper format was enormous, agencies are now encouraging applications to be submitted in eCTD format.

The main information that is included in the package is administrative information, data related to the quality, safety and efficacy of drug product, which can be submitted by CTD (Common Technical Document) format both paper and electronic version. Regulatory dossier is a package of documents, which may include all required information regarding newly developed drug products and/or generics, which is required by EU and US regulatory authorities for granting marketing authorization approvals. Introduction: What is a regulatory dossier? Nare Simonyan, freelance regulatory affairs specialist at Kolabtree, provides a comprehensive guide to a regulatory dossier and its format.

Define dossier