Dossier Format: Regulatory and procedural guidance

  • Email
  • Help

Table of contents

Application Dossier - CTD

Back to top

Application Dossier - eCTD

Back to top

Document(s) Language Status First published Last updated Effective Date
ICH: M 2: Electronic common technical document (e-CTD) - Step 5 (English only) adopted 2004-05-01 2010-09-24 2004-05-01

Electronic submissions to the European Medicines Agency

Back to top