ACUTA, ARCS, ARIM, eCTD, EMA, FDA

eCTD – What are you waiting for?

I’ve now been with ACUTA for a full year – this blog started about two weeks after I joined the company.

From that first post, we’ve been reminding you that the electronic Common Technical Document (eCTD) – the way of packaging up everything from the thousands of documents to get a drug approved, or just a cover letter, a form, and a graphic of an advertisement – is becoming mandatory. Here’s a recap of the articles on eCTD and the mandate periods:

Basically, all New Drug Applications (NDAs), Biologics Licensing Applications (BLAs) and Abbreviated New Drug Applications (ANDAs, used for generic drugs) to the Food and Drug Administration (FDA) are already required to be submitted in eCTD format. Europe also already requires eCTD for Market Authorisation Applications (MAAs) using the Centralised, Decentralised or Mutual Recognition Procedures.

Even if you’ve already submitted in a paper or Non-eCTD electronic Submission (NeeS) format, you are currently required to submit future supplements, variations, renewals, Periodic Safety Update Reports etc. in eCTD format.

What’s yet to come is filling in a few of the remaining gaps:

  • In the US, all commercial Investigational New Drug applications (INDs) and Drug Master Files (DMFs, submitted for drug and substance manufacturing information used by other companies) must be in eCTD format as of May 5, 2018
  • In Europe, MAAs using the National Procedure must be in eCTD format as of July 1, 2018, with the remainder of National Procedure submissions required January 1, 2019.

A month may not seem like a lot of time, but all is not lost if you have not yet prepared for eCTD. ACUTA Regulatory and Clinical Services (ARCS) can get you up and running for electronic submissions in days, with no setup or retainer fees. If you’re more of a do-it-yourselfer, ACUTA’s ARIM Publishing system can be configured for you in not much more time using our multi-tenant cloud, and you can be up and running creating your own eCTDs (as well as NeeS and paper submissions).

Please contact us for more information on how to get started on eCTD.

 

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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