ACUTA, ARCS, ARIM, eCTD, EMA, FDA

Your Holiday Gift: eCTD for Everything

A month ago, we reminded you that electronic Common Technical Document (eCTD) will be the rule for all US drug submissions on May 5, 2018, adding Master File and Investigational New Drug applications to the already-required New Drug Applications. What I’d neglected to mention is that eCTD is also expanding in 2018 for European submissions.

As of January 1, 2018, all new Centralised Procedure (CP) applications (not just MAAs) must be in eCTD format, but renewals and revisions may still be submitted in NeeS (Non-eCTD Electronic Submission) format

As of January 1, 2018, all Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP) submissions will also require eCTD –  which had been required for Market Authorisation Applications (MAAs), but now include variations, renewals, PSURs, etc.

As of July 1, 2018, all National Procedure (NP) MAAs must be in eCTD format, although the rest of the NP submissions will not be required until the start of 2019.

For the rest of the world, eCTD is optional in most places, and we hope to see China join the eCTD community.

As we described before, you have options for compliance:

  • Use eCTD publishing software, either cloud-based or on premise, such as ACUTA’s ARIM
  • Use services such as ACUTA’s ARCS to create your regulatory submissions

And since ARCS uses ARIM software, it provides an easy path to do-it-yourself, or for a balance of in-house review and publishing with services to meet peak periods. 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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