11.05.2011

New version of the "eValidator" released by BfArM

A new version of the "eValidator" eCTD / NeeS validation software used by German BfArM (developed by Lorenz Life Science, wwww.lorenz.cc) has been released. The new version of the "eValidator" includes a service pack that integrates the current draft EU validation criteria for eCTD (version 3.1) and NeeS (version 2.1) that will come into force on September 2011 (see our related News article from March 18, 2011 and from February 7, 2011).

After this implementation date, BfArM will reject eCTD and NeeS that do not meet the corresponding Pass / Fail criteria as outlined in the EU validation criteria. In this case, corresponding validation errors will be documented in the "eValidator" report. The name of the "eValidator" profile will be "EU" from now on as there are no more specific requirements by BfArM established. If during implementation and testing the necessity for changes occurs, these will be considered most likely after September 1, 2011 according to BfArM.

The BfArM strongly advises applicants to re-download the "eValidator" from the BfArM website and to update their local installations. During installation, applicants have the choice between the "EU1" profile (valid until August 31, 2011) and "EU2 profile" (valid from September 1, 2011). The BfArM further recommends applicants to implement the new EU validation criteria at the earliest convenience in order to gain experience early. Findings should be reported to BfArM to the attention of info-esubmission@bfarm.de.

[Source: BfArM website]

Links:

www.bfarm.de/EN/Home/news/Update_eValidator.html

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