We are pleased to announce the formation of a new Topic Group on Medical Devices and the move to electronic submissions.
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 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.
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.
How ready are you for IDMP?
EU Harmonised technical eCTD guidance v 4.0 posted – with Redaction Proposal Document Package and UUID in the envelope. Click Here
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 to coincide with ICH eCTD 4.0 Step 4 IG
EU Releases new eCTD validation criteria – Version 6.0 – updated for module 1 v3.0.
From 1 July 2016, the use of the eCTD format for all ASMF submissions for human use in the centralised procedure will become mandatory.
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.
Get ready for UUIDs
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. 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.
A draft EU eCTD Module 1 v3.0 specification was issued by the EMA on 24-Jul-2015 and is open for Public Consultation.
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.