EMEA implementation of electronic-only submissions and e-CTD submissions in the centralised procedure: Statement of intent

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Publication Date 22/01/2008
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The European Medicines Agency (EMEA), on 22 January 2008, announced plans to implement electronic-only submission of information in support of marketing authorisation applications in the centralised procedure and, ultimately, implementation of the Electronic Common Technical Document (eCTD) as the required format for electronic submissions.
Source Link Link to Main Source http://www.emea.europa.eu/pdfs/human/regaffair/56336607en.pdf
Related Links
European Medicines Agency: Q&A relating to strategic and general aspects of the imlementation, January 2008 http://www.emea.europa.eu/pdfs/human/regaffair/59687007en.pdf
European Medicines Agency: Q&A reating to practical and technical aspects of the implementation, February 2008 http://www.emea.europa.eu/pdfs/human/regaffair/59688107en.pdf
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