The Telematic Implementation Group for electronic submission and ICH Implementation (TIGes) has updated the clarification document on the draft eCTD validation criteria 3.1 that will come into force in September this year. The initial version of the clarification document was published in June (see our related News article)
In the updated version, additional clarification concerning the usage of eCTD style sheets is provided. As reported by TIGes, "several agencies noticed that for some eCTD submissions the style sheets provided by the eCTD building tools do not produce the correct MD5 checksum".
The TIGes confirms now that only the official style sheets are allowed in the eCTD as validated by correct MD5 checksums. (Note: Official style sheets for Module 2 - Module 5 are released by ICH; the regional EU Module 1 style sheet is part of the regional EU Module 1 package as released by TIGes - original MD5 checksums are provided on the download pages).
Vendors are advised to double-check the eCTD publishing tools, applicants are advised to contact their vendors in case of any deviations.
[Source: TIGes eSubmission website]
- In Verbindung stehende Artikel:
- TIGes provides clarification on the new eCTD validation criteria 3.1 - 10.06.2011 14:20
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