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Expectations for the Implementation of eCTD v4

Editor’s Note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group that developed the Regulated Product Submissions (RPS) standard. This post is the fourth in a series on the Next Major Version (NMV) of eCTD, eCTD v4.0, which is based on the RPS standard.

On December 15, 2015, the International Conference on Harmonization (ICH) endorsed Step 4 of the eCTD v4.0 Implementation Package v1.0. Step 4 signals that major stakeholders agree on guidance.

ICH released its implementation guide in early April 2016 and regulators in the US and EU followed suit.

Industry is taking very real steps to implement eCTD v4. I’ve compiled a list of expectations on timing and impact for eCTD v4.

1. The FDA will set the pace and become the first region to put eCTD v4 into production, followed in some order by Health Canada, EMA, Japan (PMDA), and the rest of the world. Legally, Europe must wait for the ratification of Regulated Product Submissions (RPS) as an ISO standard before mandating the Next Major Version (NMV) of eCTD. Europe can, however, move ahead with implementation and begin accepting submissions that take advantage of the new standard.

2. As of today, FDA expects to commence an eCTD v4 pilot testing phase in early 2018. The pilot phase should last approximately 6 months, but an extension can’t be ruled out if the Agency believes more testing is required to achieve the end goal of successful implementation. FDA also estimates that as many as 10 companies could be asked to participate in pilot testing. The FDA made this information publicly available as part of a recent solicitation to eCTD software vendors.

3. The improved eCTD v4 specification is analogous to a new version of Microsoft Office; users will benefit from new features and functionality such as simplification of lifecycle and more flexibility of dossier granularity. In our industry parlance, it should be thought of as a Module 1 update rather than a radical reinvention of current technology.

4. FDA Module 1 v2.3 (DTD 3.3), which was formally implemented on June 15, 2015, will act as a bridge to eCTD v4 . A number of distinct features of eCTD v4 popped up in the new FDA M1, namely grouped submissions and codes/display names that represent specific document types.

5. The readiness of eCTD software vendors will have a significant impact on the rollout of eCTD v4. One potential barrier to blanket implementation of eCTD v4 is industry tools for viewing, validation, and eCTD publishing that are compliant with improved standard. If, for example, vendors correctly executed the FDA M1 v2.3 update, the leap to eCTD v4 is not so significant. Simply put, eCTD v4 is a behind the scenes format change as far as software is concerned. Review users at the FDA will not experience any new functionality the day eCTD v4 goes live. As is now the case, innovative eCTD publishing systems will automate otherwise manual tasks to benefit users. One such automation for software systems compliant with eCTD v4 is the generation of Universal Unique Identifiers (UUIDs) as documents are pulled into the publishing system.

6. Consensus among vendors is that the eCTD v4 transition message was unnecessary effort that will increase the cost of product development. ICH insisted there was value and the Transition Mapping Message is still part of the equation as industry works to adopt eCTD v4. Figure 1 courtesy of ICH diagrams the message applicants must submit to transition to eCTD v4. Only “current” submission content previously submitted to a regulatory authority should be included in the transition mapping message.

eCTD 4 transition mapping message
Figure 1: eCTD v4 Transition Mapping Message

7. Sponsors will experience fewer system updates. eCTD v4 is considered a cost saving measure as systems won’t experience the frequency of updates (Module 1, validation specifications, etc.) industry has grown accustomed to in recent years. eCTD v4 uses a number of Controlled Vocabularies (CV) specified by ICH, regions, HL7, external organizations, and sender-defined, eliminating many updates required for eCTD v3.2.2.

8. Expect eCTD v4 narratives to differ from vendor to vendor. Life science companies would be wise to sync up vendor eCTD system reevaluations and the rollout of eCTD V4. Again, eCTD v4 is at its core a format change that gives users new features and functionality. If your vendor correctly handled recent Module 1 upgrades, including development that allows sponsors to view all applications in a Grouped Submission, the move to eCTD should not be a massive undertaking and expense. Talk to vendors and verify, what, if any, complexities they expect to grapple with during the transition. Vendors should be stressing a ‘keep it simple’ approach.

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By: Jason Rock

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