CRED Practical Document Writing and Management

Abbreviations

eCTD - electronic Common Technical Document NeeS – Non-eCTD electronic Submission ICH – International Conference on Harmonisation NCA - National Competent Authorities MRP - Mutual Recognition Procedure DCP – Decentralised Procedure NP – National Procedure

eDMS - electronic Document Management System CESP – Common European Submission Platform XML - eXtensible Markup Language DTD - Document Type Definition (defines a document type for an SGML- family markup language (SGML, XML, HTML))