New Topic Group - Electronic Medical Device Submissions (EMDS)

September 18, 2017

We are pleased to announce the formation of a new Topic Group on Medical Devices and the move to electronic submissions.

FDA Extends Compliance Date for Submitting DMFs in eCTD format

April 7, 2017

The FDA extended the compliance date for submitting DMF’s in eCTD format to May 5, 2018. See the FDA guidance document for additional information on the compliance date and FDA’s Drug Master File page for additional information on DMFs.

LinkedIn IRISS Forum Revitalization

November 10, 2016

LinkedIn provides a social media platform to share information across larger domains beyond the current IRISS Membership. The IRISS-Forum LinkedIn page is used to post notifications for events, webinars, announcements, and networking for followers. IRISS-Forum topic group meeting minutes, dial-in information, and records remain on the IRISS website and are accessible by members only. However, information posted to the LinkedIn IRISS-Forum page may be shared throughout social media.

If you are an IRISS member, and you would like to have an announcement published to the LinkedIn IRISS-Forum page, please send an email to [email protected].

IRISS publishes the results of readiness surveys for IDMP

October 10, 2016

The results of two surveys undertaken during August 2016 are published – an industry survey and a vendor survey. The IRISS IDMP Topic Group is a very active group and includes numerous IDMP experts, some very experienced sponsor companies and several vendors. The survey results are being made public to encourage other companies and individuals to join IRISS.

Blog: IRISS Forum Industry Survey of IDMP Readiness

October 3, 2016

How ready are you for IDMP?

EU Harmonised Technical eCTD Guidance Updated

May 3, 2016

EU Harmonised technical eCTD guidance v 4.0 posted – with Redaction Proposal Document Package and UUID in the envelope. Click Here

ICH Publishes eCTD 4.0 Step 4

April 1, 2016

The ICH M8 Expert Working Group (EWG) has published the eCTD v4.0 Step 4 Implementation Guide and related files.

FDA posts eCTD v4.0 Module 1 Implementation Package

April 1, 2016

FDA posts eCTD v4.0 Module 1 Implementation Package to coincide with ICH eCTD 4.0 Step 4 IG

EU Releases new eCTD validation criteria – Version 6.0

February 29, 2016

EU Releases new eCTD validation criteria – Version 6.0 – updated for module 1 v3.0.

EMA: eCTD Mandatory Format for ASMF Submissions for Human Medicines as of July 1, 2016

January 26, 2016

From 1 July 2016, the use of the eCTD format for all ASMF submissions for human use in the centralised procedure will become mandatory.

EMA eCTD Validation Criteria 6.0

November 16, 2015

New validation criteria posted for public comment.The changes in the validation criteria relate mainly to the updated EU Module 1 eCTD Specification v.3.0 to come into force 1 July 2016 and Mandatory from 1 October 2016.

EU eCTD M1 Version 3.0 released

October 21, 2015

Get ready for UUIDs

FDA Issued New eCTD Technical Conformance Guide

October 7, 2015

The guide provides specifications, recommendations, and general considerations on how to submit eCTD – based electronic submissions to CDER or CBER. It covers the electronic submission of INDs, NDAs, ANDAs, BLAs, and master files.

ICH Recommends DOCX as a Submission File Format

August 25, 2015

ICH Recommends DOCX as a Submission File Format. DOCX is an ISO standard and has the ability to contain custom embedded XML elements making it suitable for the submission of structured information. It is the default file format of MS Word.

EU eCTD M1 Draft Specs v3.0 for Public Consultation

August 2, 2015

A draft EU eCTD Module 1 v3.0 specification was issued by the EMA on 24-Jul-2015 and is open for Public Consultation.

TGA Australia - Paper Dossiers are no Longer Required to Accompany eCTD

July 7, 2015

Prescription medicine sponsors can now submit dossiers to the TGA in the electronic Common Technical Document (eCTD) format.

Paper dossiers are no longer required to accompany eCTD formatted submissions, following the success of the pilot programme between January and June 2015.