The EURS (European Review System for eCTDs) is envisaged as a shared solution for the processing and review of eCTDs in the European Procedures. A final EURS solution was selected in December 2006 after a lengthy period of assessment and evaluation of tools and gathering of experience involving EMA and National Competent Authorities. This solution is to be made available to all Member States that choose to implement it. In May 2007, an EURS implementation Group was formed as a subgroup of the eSubmission TIG to progress the implementation of the EURS, develop further requirements and resolve issues.

Status Reports

• EURS status report - April 2011 can be viewed here
• EURS status report - January 2011 can be viewed here

Click the below links to find information about:

• Objectives and Timelines (.ppt presentation)
• Specifications
• EURS Implementation Group Terms of Reference (.ppt presentation)
• EU Validation Criteria v2.1
• New validation criteria v3.0 (effective 1 September 2011) -NEW
• A list of Member State contact points for EURS queries can be viewed here (.xls)

Note: Tool used to generate the EU Module 1 checksum from http://www.slavasoft.com/hashcalc/index.htm

• EU Module 1 v1.4 checksum for eu-regional.dtd is: 91654e96e3bafc5e89df7f892477b246
• EU Module 1 v1.4 checksum for eu-envelope.mod is: 664a76e3f31a9553d3375d3b21815904
• EU Module 1 v1.4 checksum for eu-leaf.mod is: 2e976bc60658a964affa5026369a371e
• EU Module 1 v1.4 checksum for eu-regional.sl is: 54f9889822e1d08cc23b902fc6a66aaa
• EU Module 1 v1.3 checksum for eu-regional.dtd is: 12e5c2a5e901f336523fab644ca1a444
• EU Module 1 v1.3 checksum for eu-envelope.mod is: 465c4813362aca1073b9de94aff63e9c
• EU Module 1 v1.3 checksum for eu-leaf.mod is: 039bfb13f93442beda41e8e0030f8cf8