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, August 2009 | http://esubmission.emea.europa.eu/eumodule1/docs/EU M1 1.4/EU M1 Specifications v1.4 FINAL.pdf Effective 1st January 2010, when the new variation regulation comes into force, the EU M1 v1.4 must be used for any eCTD submission for any European procedure that contains grouped variations or is subject to a worksharing agreement. Effective 1st July 2010, the EU M1 v1.4 must be used for all eCTD submissions for all European procedures. |
| Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD electronic Submissions | Draft, 1.0, May 2009 | http://esubmission.emea.europa.eu/doc/eCTD Guidance Document 1.0 FINAL FOR PUBLICATION.pdf |
| Guidance for Industry on Providing Regulatory Information in Electronic Format: Non-eCTD electronic Submissions (NeeS) | 1.4, Jan 2008 | http://esubmission.emea.europa.eu/doc/eGuidance_Document_1.4.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://esubmission.emea.europa.eu/doc/PAPER Accompanied by eCTD and NeeS Guidance Final March 2010.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/WC500004094.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/pdfs/human/regaffair/63391908en.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.emea.europa.eu/pdfs/human/regaffair/57784208en.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 | v2.1, Apr 2009
3.1, Feb 2011 (effective Sept 2011)
| http://esubmission.emea.europa.eu/doc/EU Validation Criteria v2.1 - April 2009.pdf http://esubmission.emea.europa.eu/doc/newdocs/newesub docs/eCTD Validation Criteria_2011-02-11 v3-1.xls |
| 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 |