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Documentation

ICH

• ICH: http://www.ich.org
• ICH electronic Common Technical Document (eCTD): http://estri.ich.org
• ICH Specification 3.2 (Modules 2 - 5) (Notice to Applicants Vol 2B): http://estri.ich.org/eCTD/index.htm
• ICH Q&As: http://estri.ich.org/ectd
• ICH M4 Granularity: http://www.ich.org/LOB/media/MEDIA554.pdf
• ICH ETICS M2 Project: http://www.etics.us

Eudralex Volume 2 - Pharmaceutical Legislation: Notice to Applicants

• http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/index_en.htm

For consultation: Final Draft EU M1 Specification 1.4.1 - NEW

New Variation Regulation and eCTD

• A question-and-answer document covering practical issues of eCTD dossier submission and handling under the new variations regulation is published by CMDh and The European Medicines Agency and is available here. Comments on the guidance are welcomed, and it is anticipated that the document will be updated as more experience is gained. Comments on the guidance should be sent to eCTD@ema.europa.eu. A review of the document will be carried out at the end of June.

eCTD and ASMF

• A joint working group comprising representatives from EU Regulatory Authorities, The European Medicines Agency, industry, EDQM and ASMF holders has drafted a guidance document covering practical and technical points related to the submission and handling of the ASMF in eCTD. As this is a final draft, the guidance should be implemented, but as experience with eCTD and ASMF is gained, comments are actively sought, with a view to updating the guidance as necessary in July 2010. The document can be viewed here and an example eCTD ASMF can be downloaded here. Comments on the document should be sent to eCTD@ema.europa.eu

EU Change Control Process

• Latest agreed EU Telematics EU eCTD Change Request/Q&A Tracking Table (May 2012) NEW
• The new agreed Change Request Process (June 2011) NEW
• The Electronic Submission Change Request Q&A form (June 2011) NEW

General eSubmission Links

• ICH M2 (Q&A or Change Request Form)
• EMA Q&A24 regarding eSubmission
• eCTD Plasma Master File Guidance

EMA eSubmission Guidance for the Centralised Procedure

• All EMA guidance documents, both practical and strategic, as well as Statements of Intent relating to eCTD and electronic submissions, can be found on the EMA external website at http://www.ema.europa.eu/htms/human/raguidelines/dossier_format.htm

National Agency e-Submission Guidance

• Austria
• Belgium
• Denmark
• IMB, Ireland
• France (AFSSAPS)
• Germany (BfArM)
• Netherlands (MEB)
• Spain
• Sweden
• United Kingdom (MHRA) (Special Mail 5)

Contact Points

• A list of Member State Contact Points has been compiled both for the submission of eCTDs to each agency, and the submission of electronic PSURs to each agency. This list can be viewed here
• A list of Member State contact points for EURS queries can be viewed here