The European Take on eCTD Submissions

EUROPEAN MEDICINES AGENCY GUIDANCES

As of January 2010, European Medicines Agency (EMA) will no longer accept NeeS (all eSubmissions must be eCTD).

See the eCTD Implementation Survey Report for an update on where the Heads of Agencies stand on complete eCTD acceptance.  HMA also provides a useful map showing the status of electronic submissions throughout the EU.

The following table summarizes the eCTD-related guidance documents issued by the EMA:

 

EMA eCTD Guidance Documents




Document Issue Date URL

EU Module 1 Specification

 

1.4.1, Nov 2011

http://esubmission.emea.europa.eu/eumodule1/docs/EU%20M1%201.4.1/EU%20M1%20v141_Spec%20_Nov2011_FINAL.pdf
Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD electronic Submissions 2.0, Mar 2010 http://esubmission.emea.europa.eu/doc/NeeS%20eGuidance%20Document%20version%202.0.pdf
Guidance for Industry on Providing Regulatory Information in Electronic Format: Non-eCTD electronic Submissions (NeeS) 2.0, Mar 2010  http://esubmission.emea.europa.eu/doc/NeeS%20eGuidance%20Document%20version%202.0.pdf
Practical guidance for the paper submission of regulatory information in support of a marketing authorisation application when using the Electronic Common Technical Document (“eCTD”) or NeeS as the source submission. 2.0, Mar 2010 http://ec.europa.eu/health/files/eudralex/vol-2/ectdpaper_v2.pdf
EMA Implementation of Electronic Submissions and ECTD Submissions: Statement of Intent: Questions and Answers Jan 2008 http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004095.pdf
EMA Implementation of Electronic-Only Submission and eCTD Submission: Practical Guidelines Relating to Non-eCTD Electronic Submissions 1.0, Dec 2008  http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004100.pdf
EMA Implementation of Electronic-Only Submissions and Mandatory eCTD Submissions In The Centralised Procedure Statement Of Intent Relating To Non-eCTD Submissions  Dec 2008  http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004099.pdf
EMA Implementation of Electronic-Only Submissions and Mandatory eCTD Submissions In The Centralised Procedure: Statement Of Intent Dec 2008 http://www.emea.europa.eu/pdfs/human/regaffair/57245908en.pdf
EU eCTD Validation Criteria

v3 and 3.1, Mar 2011

 

http://www.google.com/url?sa=t&rct=j&q=eu%20ectd%20validation%20criteria&source=web&cd=2&ved=0CCYQFjAB&url=http%3A%2F%2Fesubmission.emea.europa.eu%2Fdoc%2Fnewdocs%2Fnewesub%2520docs%2FRelease%2520Notes%2520v1%25201_to%2520eCTD%2520and%2520NeeS%2520Validation%2520Criteria_for%2520publication%2520March%25202011.doc&ei=6xl2UOy5Gsew0AHsyIGABA&usg=AFQjCNH-zcY_1SbtPvHZ7xj1D45XCGN1jA

http://www.google.com/url?sa=t&rct=j&q=eu%20ectd%20validation%20criteria&source=web&cd=3&ved=0CCsQFjAC&url=http%3A%2F%2Fesubmission.emea.europa.eu%2Fdoc%2Fnewdocs%2FeCTD%2520Validation%2520Criteria_2011-01-19_adopted%2520by%2520TIGes%2520as%2520version%25203.0.xls&ei=6xl2UOy5Gsew0AHsyIGABA&usg=AFQjCNEupaDLvG9l8hlXRLXmG8waGMyEMA
EMA Implementation of Electronic-Only Submissions and eCTD Submissions in the Centralised Procedure: Statement of Intent Jan 2008 http://www.emea.europa.eu/pdfs/human/regaffair/56336607en.pdf