Category: ARIM

ARIM, EMA, IDMP

And if IDMP never happens?

Well, for one, it will. European Parliament has legislated that it must.  But it could come in many different forms, perhaps with nothing more than the minimal data to determine a Medicinal Product ID that gets used on an Adverse Event Report. That means the following items are the barest minimum of data that must be …

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) …

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 …

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 …

ARCS, ARID, ARIM, FDA, Uncategorized

Last Minute Help on FDA Marketing Status Report

The US Food and Drug Administration (FDA) wants your valentines, or at least a letter saying that you love them so much, because they accurately listed your products in the “Approved Drug Products with therapeutic Equivalence Evaluations,” better known as the Orange Book. As part of the FDA Reauthorization Act of 2017 (FDARA), there is …

ACUTA, ARIM, Australia, Canada, eCTD, South Africa, Validator

ARIM 2.3.3 hotfix 11 and ARIM Validator 3.2 Released: Canada, Australia, South Africa updates

ACUTA has released new versions of ARIM 2.3.3 Hotfix 11 and ARIM Validator 3.2 (desktop). The primary features included in this release are: Support for South Africa (ZA) Validation specifications v2.1 Support for Australia (AU) v3.1 Validation and eCTD specifications. Support for Canada (CA) Validation specifications v4.2 Other cool enhancements: The license key can now …

ARIM, EMA, IDMP

IDMPrimer: What we don’t know

IDMP Club

It seems the first rule of IDMP Club is the same as Fight Club: Don’t talk about IDMP Club (it’s probably the second rule too). I’m a member of some of the branches of IDMP Club, but not all. IRISS Forum probably has the most open exchange of information. I’d highly recommend joining if you …

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. …