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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.
The evolution of the Electronic Common Technical Document (eCTD) has been a progression. More features and functionality become available to users as new versions are introduced. User adoption of eCTD also increases year over year. FDA Module 1 v2.3 (DTD 3.3) is a bridge to eCTD 4. A number of functionality enhancements set for inclusion in eCTD v4 first appeared in the new FDA M1 but were not present in FDA eCTD M1 (DTD 2.01). The shared features, presently implemented in FDA M1 v2.3 (DTD 3.3) and included in eCTD 4, are coded metadata, in the form of Controlled Vocabularies, and Grouped Submissions.
Foreign sponsors of drug applications who want to conduct business in the United States need an authorized U.S. Agent to interact with the FDA on their behalf. Expectations for the individual or company serving as the U.S. Agent should go beyond forwarding email and monitoring the fax machine. The U.S. Agent should add value in the form of regulatory insight and operational efficiency as you navigate the FDA apparatus.
In a notice posted to its website, Health Canada gave advance warning that the agency is considering an eCTD filing requirement, or eCTD mandate, that would take effect as early as January 1, 2018. Health Canada is asking for stakeholders to submit comments by August 31, 2016. Comments can be sent to email@example.com.
eCTD templates set the tone at the early stage of drug development for a smooth, standardized presentation of information in future regulatory submissions. Templates are favorable when compared to creating documents from scratch. Authoring templates make it easier to write summary documents and easily repurpose information from multiple reports without worrying about reformatting. High-quality documents are a precursor to successful submissions. Leveraging templates is one way to help make this possible.
The focal points of eCTD v4.0 like document reuse, enhanced lifecycle control and more liberal use of metadata, and the ability to alter that metadata if errors are made, are countermeasures to the limitations of eCTD v3.2.2. Overall, these enhancements represent common sense solutions that give regulatory professionals a more efficient way of doing business.
Much fanfare has surrounded the Next Major Version (NMV) of eCTD or eCTD 4 since the group I chaired formed in 2005 and developed initial requirements for the standard. You’ve likely sat in on eCTD 4 presentations at industry conferences and heard secondhand of the deliberations, ballots and revisions going on behind the scenes. In short, we’ve all been waiting for things to happen. Well, things have happened. As a member of the Expert Working Group (EWG) first tasked with developing eCTD 4, I’m proud to report that agencies, vendors and sponsors in each ICH region can get started on implementation. ICH announced that it had reached Step 4 and adopted a harmonized guideline on the eCTD 4 Implementation Package for Modules 2 through 5. Let’s review some of the key concepts of eCTD 4 to get an idea of what will change when this standard is implemented down the road.
In recent weeks, sponsors filing eCTD submissions to FDA have reported instances of Refuse to Receive (RTR) notifications for failure to provide a fillable Form 3674. These actions indicate that the Agency is stepping up enforcement in this area as it aims to process even more submissions automatically. Using industry presentations and guidance documents, FDA has previously stated that sponsors “must” include fillable forms. The Agency has also made it clear that scanned images of FDA forms “will not be accepted.” Based on the information made public by FDA to date and the experience of sponsors in recent months, the most logical strategy moving forward is to provide a fillable form where one is available.