What is an eCTD Dossier in Pharma Manufacturing?

The electronic common technical document (eCTD) is the principal digital format pharmaceutical companies use to register drugs from human use with a regulatory agency as adopted by the International Conference on Harmonisation (ICH). The eCTD dossier is the collection of files, data and information that are required to be contained in an eCTD drug submission by a regulatory body. An eCTD dossier is more commonly called a new drug application (NDA) in the U.S. and a marketing authorization application (MAA) in the European Union and other countries.

10 Common Pains in Dossier Management & Product Registration
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