Tag: eCTD

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 …