International Trends in Drug Registration and Evaluation [Part 2: eCTD v4.0]

Our last blog post on this topic covered eCTD v3.2.2 and its advantages over paper or non-eCTD electronic submissions. The main selling points of v3.2.2 are its reliable presentation of information to reviewers, the level of flexibility for national authorities, the metadata for automated processing, the life cycle information on documents, and the reuse of information.

In this second part of our series about international trends in drug registration we dive into the improvements from eCTD v4.0 over eCTD v3.2.2.

eCTD v4.0
The ICH M8 group has developed the next major version of the eCTD. Based on the HL7 RPS standard, the implementation guide for eCTD v4.0 is now available as version 1.2 on the ICH website. Implementation projects are under way at the EMA, Health Canada, Japan´s PMDA, and the USFDA.

The eCTD v4.0 offers the same advantages as eCTD v3.2.2 with some additional improvements in functionality:

  • Increased harmonization – In the previous version, the ICH backbone XML file is separated from the regional backbone XML file. In the updated version, all information and metadata in the message can be transmitted in a single XML backbone that has been harmonized. This will make for even simpler reuse of information for regulated industry and more efficient reviews or sharing of information for national regulatory authorities.
  • Easier message maintenance – In eCTD v4.0 the submission metadata from the XML backbone files is separated, and the lists of valid submission metadata (controlled vocabularies) are maintained in separate files. This means the lists can be updated or changed without affecting the rest of the backbone file. This leads to easier maintenance for eCTD tool vendors and for national authorities. It will also lower the cost of updates.
  • Document reuse – eCTD v4.0 provides a clear way for the industry to identify where documents that have already been submitted to a national regulatory authority can be applied to new applications without resubmitting the file. This reduces the size of messages that must be transmitted to the regulatory authority while also reducing the number of duplicate files in a repository that must be stored by the regulatory authority. For the reviewer, the eCTD review tool will indicate where documents have been reused. This can lead to more efficient evaluations if a reviewer is already familiar with a specific document.
  • Two-way communication – To improve processes for communicating with regulatory authorities, the eCTD v4.0 was developed as a two-way messaging standard. The ability to replace mailed or faxed documents with instant electronic communication will provide benefits to both authorities and regulated industry. On the regulated industry side, this can enable automated processes to receive information and inform the relevant parties. It can also trigger necessary events such as the release of products for clinical trials, or the halting of a trial due to a regulatory issue with the trial itself.

Regulatory authorities continue to draft their technical specifications for eCTD v4.0 and adapt their internal regulatory processes and systems to prepare for the transition to eCTD v4.0 and the implementation of two-way communication.

LORENZ will be supporting eCTD v4.0 for both our authority clients and our regulated industry customers as soon as it comes into force. In fact, we piloted the eCTD 4.0 at concept stage together with industry and agency representatives back in 2016!  This included testing of the complete lifecycle with the industry as compiler and the agencies as reviewer. As we have demonstrated in the past, we will continue to support any new or changed national specifications before the new version is required, with adequate time to support internal and pilot testing with the target authority. Thanks to our regular and reliable release schedule, every April and October, we are able to capture regional updates and provide our customers with a dependable rhythm for planning their own upgrades to ensure compliance with the latest regulatory requirements.

Outlook for Part 3:
In part 3 of our series, you will hear about ISO IDMP and Master Data Management. There will also be a preview of future directions for the interoperability of systems.

Christian KaasWritten by Jared Lantzy, Manager Global Regulatory Agencies and Processes at LORENZ Life Sciences Group.

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