The structure of CTD CTD-Module 1 Specifications for US Module 1: Administrative Information and Prescribing InformationĮ-CTD Module 1 section contains administrative and labeling documents.
#A dossier definition code
The process of submitting regulatory dossier is regulated by Code of Federal Regulations (CFR) (Law in US) and Directives (Law in EU).įigure 1.
All Drug Master Files (DMF) and Active Substance Master Files (ASMF) must follow the structure of the CTD. With additional guidance and guidelines from the FDA and EMA, the CTD is now required for all applications, including those for clinical trials-IMPD and INDs.
#A dossier definition license
The CTD was primarily used for new marketing applications such as NDA, BLA (Biologics License Application), MAA, NDS (New Drug Substance), JNDA (Japanese New Drug Application), etc. The CTD structure applies to both investigational and commercial applications (IND (Investigational New Drug) and NDA (US) IMPD (Investigational Medicinal Product Dossier) and MAA (EU), and global applications). 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.
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