ARIM Publisher, eCTD, EMA, Regulatory Update

Regulatory Update: EMA eCTD Specifications 3.0.2 – Best Practices Limitation Corrected (even better practices!)

On April 6, 2017, EMA issued a new version of the eCTD specifications, version 3.0.2, 11 months after version 3.0.1. If you look at the EMA Website’s EU Module 1 page, it appears that nothing has happened: The same EU Regional DTD (the structure of the eCTD), and the same Implementation Guide are listed as for 3.0.1. Neither the DTD version number, nor the checksum, have changed.

In fact, if you read the release notes and EMA’s a Q/A document on the subject, it ends with a statement that the new criteria listed won’t be put out as a new validation version until March of 2018.

However, EMA has added two new Best Practice rules, for how grouped and workshare submissions are used. Following those new rules caused a validation message of “BP” (Best Practices) level in ACUTA Validator (AV) because of a strict interpretation of the Best Practices rules 14.BR4 and 14.BR5.

Specifically, when grouping several variations for a single product, the rules require that no submission number be used, but AV required the number. This was not explicit in the 3.0.1 specifications Best Practices rules 4 and 5 (regarding high-level submission numbers for grouping and workshare), but is clarified in new Best Practices rules 14.BR7 and 14.BR8.

ARIM version 2.3.3 Hotfix 9 and version 3.0.1 Hotfix 1, and an update to the ACUTA Validator (AV) will be released on Friday, June 9. Those versions’ validation rules are enhanced to permit the use of a blank high-level submission number on grouped variations for a single marketing authorisation The validation report will no longer issue a Failed message in these “BP” validation items.

Below is the history of EU Regional Specifications, the associated DTD number and validation version. ARIM will only permit you to create using the latest version, but submission sequences in earlier versions may be imported and validated.

Region Specification Document Date DTD Version Validation Criteria Version
EU 1.4.1 Nov 2011 1.4 4.0
2.0 27-Feb-2013 2.0 5.0
3.0 07-Oct-2015 3.0 5.1
3.0.1 07-Dec-2016 3.0.1 6.1
3.0.2 06-Apr-2017 3.0.1 6.1

There is still a remaining issue in the ARIM Publishing module where out-of-sequence submissions generate a validation error. This will be corrected in the next Minor release.

For ACUTA Cloud users of ARIM, the new version will be installed automatically. For on-premise sites, please contact support to download the hotfix.

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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