Tag: eCTD

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 …

ACUTA, ARCS, ARIM, Australia, eCTD, NeES

E-Submissions Looking Up Down Under

Australia’s Therapeutic Goods Administration (TGA) released updated guidance for both eCTD (electronic Common Technical Document) and NeES (Non-eCTD Electronic Submissions). Version 3.1 of the Australian regional eCTD specifications, and version 2.0 of the NeES specifications will be accepted starting January 1, 2018, and will be mandatory July 1, 2018. Because the eCTD and NeES are …

ACUTA, ARIM, ARIM Publisher, eCTD, EMA, FDA

Lots of Regulatory Activity Going On

Welcome to another episode of Fun With RIM (kidding, this is the first one). Today’s topic: Just what is a Regulatory Activity? You’ll say to yourself, “I’m in Regulatory, and I do things, so those must be Regulatory Activities.” Not counting that 15 minutes to two hours that half the workforce spends every day on …

ACUTA, ARIM, Software Release

ACUTA Ships ARIM 3.1, ARIM 2.3.3 and Validator

As you can see in the photo above, we have been putting tremendous effort toward shipment of the latest releases of the ARIM (ACUTA Regulatory Information Management) system. Shy Kumar, Founder and CEO of ACUTA, said this of the new releases: The ACUTA team continues to innovate with a focus on bringing new capabilities and …

ACUTA, APT, ARIM Publisher, eCTD

PDF Links Feel So Broke Up, I Want to Go Home

PDF in Electronic Submissions Before there was eCTD (the electronic Common Technical Document), there were submissions using just PDF – the Portable Document Format created by Adobe (and before PDF, there were submissions using interactive PostScript, TIFF images, DAMOS, etc., but that’s a scary story for another time, perhaps around a campfire) The PDF file …

ARIM Publisher, eCTD, EMA, Regulatory Update

Regulatory Update: EMA eCTD Specifications 3.0.2 – Best Practices Limitation Corrected (even better practices!)

On April 6, 2017, EMA issued a new version of the eCTD specifications, version 3.0.2, 11 months after version 3.0.1. If you look at the EMA Website’s EU Module 1 page, it appears that nothing has happened: The same EU Regional DTD (the structure of the eCTD), and the same Implementation Guide are listed as …

eCTD, eCTD 4, EMA

eCTD 4 in Europe: Multiple Countries, Multiple Processes

For the first time in two years, EMA (there are enough acronyms here that it got distracting defining them all – see the table at the bottom) has updated their Implementation Guide for eCTD version 4, which is based on the HL7 RPS standard, and has been advanced through ICH Step 4, meaning that it’s OK …

eCTD, EMA, Health Canada, Regulatory Update

Regulatory Updates: European Electronic Application Form and Health Canada eCTD Mandate

Joel Finkle, Director Regulatory Innovation and Donald Palmer, Director Product Strategy A couple of announcements have been received from regulatory agencies impacting product application processes. European Electronic Application Form (eAF) First, EMA has updated the electronic Application Form (EAF). This is the interactive PDF form from which EMA extracts an XML representation of what your …

eCTD, eCTD 4, FDA

eCTD 4 — A Love/Hate Relationship

Joel Finkle, Director Regulatory Innovation & IDMP Strategy, ACUTA Don’t get me wrong: I definitely love eCTD 4 for all the things it’s been designed for. However, we’ve been working on it since 2005, and we’re still years away from its full implementation.  So, I thought I’d make a love and hate list to show …

ARCS, ARIM Publisher, eCTD, eCTD 4, FDA

eCTD – It’s not just a good idea, it’s the law

Joel Finkle, Director Regulatory Innovation & IDMP Strategy Note: This post appeared previously on LinkedIn.com Some of you have been following my writing for a few years; I’ve got a new home at Acuta. For others, this may be the first you’ve seen of my posts. I’ve been involved with electronic regulatory submissions since 1991 …