ACUTA, ARCS, ARIM, eCTD, FDA

Six Months until Mandatory eCTD for INDs, DMFs at FDA

Almost seven months ago, I posted my first ACUTA blog entry on the FDA requirement for eCTD for all marketing applications, a little under a month before the May 5, 2017 deadline. The sky didn’t fall, companies didn’t fold for being unable to comply… and ARCS (ACUTA Clinical & Regulatory Services) helped numerous companies achieve their eCTDs for submission to FDA (and other agencies).

We’re now about six months away from the second half of that deadline: Companies submitting commercial Investigational New Drugs (INDs) and Drug Master Files (DMFs) will be required to send them to FDA electronically in eCTD format. Paper submissions will no longer be accepted except for non-commercial INDs, such as those from research institutions.

The eCTD format is an XML-based “envelope” that serves as the table of contents for a set of documents, mainly in Adobe Acrobat (PDF) format, plus some datasets and label documents in other formats. The eCTD standard has been in use since 2002, and is currently adopted in the US, Europe, Japan, Canada, Switzerland, South Africa, Australia, New Zealand, The Gulf Cooperation Council, and Thailand, with other countries joining regularly. Of those, the US, Europe, and Canada require some or all of the regulatory submissions to be in eCTD format.

The only remaining question, is how you will achieve compliance. Publishing regulatory submissions, even for the start of the Investigational New Drug process can quickly get beyond what can be done with desktop productivity tools – even if you were preparing paper submissions. Just cross-referencing between summaries and related documents can be a pain. A Regulatory Information Management system such as ACUTA’s ARIM (you should be able to guess what that acronym stands for even if you haven’t seen it before) can assemble and publish submissions in eCTD format easily.  Those cross-references can be handled easily without pain.  ARIM’s cloud implementation can make getting started much faster than on-premise software, but most companies using it will need to have resources trained in its use.

Many companies, whether they are small start-ups without dedicated regulatory operations staff, to Tier-1 corporations that see operations as “not a core competency,” have been switching to outsourced services to produce regulatory submissions. ACUTA’s ARCS has regulatory operations experts that can assist with the production of the documents in the submissions, all the way up to creating and submitting the eCTD submissions to agencies. Quality has been unsurpassed, with not a single refuse-to-file or refuse-to-accept outcome on any project we have produced for our customers.

Since ARCS uses ACUTA’s software, including ARIM and APT (ACUTA PDF Tools), and provides customer review access to the ARIM environment, it’s easy to move up to using the software yourselves as your company grows, or just continue using services to fulfill all your regulatory operations needs.

Contact ACUTA for more information on how we can make your company eCTD experts.

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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