Tag: eCTD

eCTD, eCTD 4, FDA, IDMP, Medical Devices

2019 FDA Goals: A Christmas Wish List

Image Credit Angie Chapman https://www.flickr.com/photos/angiet-cakefiend/7178335187/in/photolist-bWjQXM-5Nzjum-5Nvcrt-5MeAEL-2ixWd-5NvaLF-CZcM4n-7YXyHM-5eEVdZ-5eEVe6-VRZQJ5-97o4ku-FW4xX-64CNCY-X6HEUo-J3XeKS-5DgNxm-gBhhE5-X6HJ3N-7gZ4bC-5DgMhq-6khfTX-e9C6ZZ-5DcxDx-9HBaiw-nBqP7w-qBzhoK-hJYfj5-aoQA8J-iRdUdr-WTnycN-8UrP3g-7giMG1-XFeizH-8V8zy8-K6Azn-ZatFom-6z6eQG-8aNvz2-79G6Dg-XU8uhv-WntgLm-5LLfFN-SJLA7d-SKt1sH-K6kTf-QQfE51-Ujfch7-asm29b-ei5nx9

RAPS Regulatory Focus reported from the December 11, 2018 CMS/FDA Summit in Washington DC, as to Janet Woodcock’s goals for FDA in 2019. There was a focus on health, opioids, supply chain safety… all the stuff for which we all need the agency to excel, but I’m here for the changes in regulatory approval processes, …

ACUTA, ARIM, eCTD, Switzerland

SwissMedic Updated eCTD Guidance November 2018

On November 1, SwissMedic, the regulatory agency for Switzerland, updated their guidance for eCTD, including a new version 1.4 of the Data Type Definition (DTD), and validation rules. This corresponds to the recent Revision 4 of the Therapeutic Product Ordinances (HMV4). These rules area available starting January 1, to become mandatory in June. If you …

ARIM, ARIM Publisher, Australia, eCTD, RIM+

Australia Proposing Mandatory eCTD starting 2019

In late October 2018, Australia’s Therapeutic Goods Administration (TGA) opened consultation regarding their proposed schedule to make eCTD mandatory for prescription drug dossier submissions. The full proposal document can be found at the link above.

ACUTA, ARIM, ARIM Publisher, eCTD, FDA, Uncategorized, Validator

FDA Validation Criteria to change July 27

On June 21, FDA announced changes to their eCTD validation criteria, to be implemented on July 27. The first is to remove a low-severity item, #5025, which would highlight the lack of PDF-fillable forms. The rest are a set of new validation rules, numbered 1-7, that were previously part of their Submission Acceptance criteria — …

ACUTA, ARIM, Conferences, eCTD

ACUTA RIM Shots May 18, 2018

Every once in a while there will be only short subjects to report on Regulatory Information Management-related topics, so welcome to the first ACUTA RIM Shots, where we’ll report on quick news items. ACUTA to Present at Pharmaceutical Regulatory Affairs June 8 Joel Finkle, Director of Regulatory Innovation and IDMP Strategy, will have two presentations …

ACUTA, ARIM, Australia, eCTD, Validator

ACUTA Validator now listed by the Australian agency

In November of 2017, we reported the details of Australia’s updated guidance for version 3.1 of their regional eCTD specifications. ARIM Suite Version 3.2, which was released shortly after that, provided full support for publishing and validating Australian submissions. While ACUTA Validator has been capable of accurately validating submissions to Australia’s Therapeutic Goods Administration (TGA) …


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 …

ACUTA, ARCS, ARIM, ARIM Publisher, FDA, Software Release, Validator

Getting your STF in order

In 2003, ICH introduced the Study Tagging File (STF) in the electronic Common Technical Document (eCTD) format for electronic submissions to facilitate a way to associate all the documents and data files for a study. Initially the specification included two possible approaches for versioning the study’s items: Cumulative: A complete cumulative STF would be provided …

Canada, eCTD, eCTD 4, EMA, FDA, Health Canada

eCTD 4: Everybody in the pool! But no running!

This year’s Regulatory Information, Submissions, and Document Management forum presented by the DIA took place February 4-7 in Bethesda Maryland. I saw a lot of old colleagues from my employers over the decades, now dispersed throughout the industry, and heard a lot about where Regulatory Information Management is heading. For me, the most fascinating part …


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. …