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@ectdexperts

Latest news from Exalon and updates from Regulators, Pharmaceutical Industry and other Stakeholders.

 Radolfzell (Germany)
exalon.com
Joined March 2010
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Photo by exalon (@ectdexperts)Photo by exalon (@ectdexperts)Photo by exalon (@ectdexperts)Photo by exalon (@ectdexperts)
A short reminder from EU EMA regarding the proper naming of electronic application forms (eAF) for centrally authorized products #eCTD #EMA esubmission.ema.europa.eu/
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For EU Type IA/Type IAin Variations, a cover letter is no longer required. (Source: EMA, CMDh). The requirement to include a Sequence Tracking Table remains. #RegulatoryAffairs #eCTD
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September 1st is approaching fast - please be reminded of the mandatory use of the PLM web-based eAFs for EU Centralized Procedure submissions! esubmission.ema.europa.eu/ce…
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FDA issues Draft Guidance on Container Closure Systems for Human Drugs and Biological Products fda.gov/regulatory-informati…

Guidance for Industry

Container Closure Systems for Human Drugs and Biological Products

fda.gov
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Swissmedic publishes updated Implementation Guide v1.1 for eCTD 4.0 #eCTD4 #eCTD and will complete technical implementation of eCTD 4.0 by end of 2026; the standard will go live during 2027 once pilot testing has been completed - expect FAQs in 2027. swissmedic.ch/swissmedic/en/…

eCTD v4.0

Swissmedic is publishing version 2.0 of the package for the Swiss Implementation Guide

swissmedic.ch
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EMA announces launch of eCTD v4.0 pilot phase III on forward compatibility for EU Centrally Authorised Products esubmission.ema.europa.eu/ #eCTD4 #EMA #DrugRegulatory
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Final EU eCTD v4.0 Validation Criteria v1.1 out now – fresh from EMA! Rules updated, changes tracked, file naming best practices included. Applicable 15 July 2026. Who's already testing v4.0 submissions? Drop your thoughts below esubmission.ema.europa.eu/ #eCTDv4 #EMA
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Don't let your submissions stall! A quick reminder on the latest EMA variation classification updates and the impact on your eAFs. Action Required: Double-check accuracy of selected scopes & documentation. Issue Found? Raise a ticket in the Service - Center!
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Source: esubmission.ema.europa.eu/ RMS Service - Employee Center: support.ema.europa.eu/
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Pharmaceutical industry stakeholders are seeking clearer implementation guidance for the transition to ICH M4Q(R2), particularly on timelines, legacy product handling, and minimizing rework for existing dossiers. Read the RAPS article: #ICH #eCTD raps.org/news-and-articles/n…

News & Insights Search

raps.org
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FDA & EMA urge pharma to pilot eCTD 4.0 now! EU mandate hits 2027 for centralized products; FDA eyes 2029. Early testing = smoother submissions. Who's joining the pilot? #eCTD #RegulatoryAffairs #PharmaTech
exalon (@ectdexperts) profile pictureexalon@ectdexpertsFeb 4
FDA, EMA officials encourage companies to pilot eCTD 4.0 raps.org/news-and-articles/n…

News & Insights Search

raps.org
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FDA, EMA officials encourage companies to pilot eCTD 4.0 raps.org/news-and-articles/n…

News & Insights Search

raps.org
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The end of the year is a perfect moment to say thank you. We are grateful to our customers, partners, and team for a year of cooperation and shared success. Season’s Greetings and best wishes for the New Year from Exalon!
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EMA go-live for EU #eCTD v4.0 optional use for CAP new MAAs. Applicants must contact EMA eCTD v4.0 team prior to any eCTD v4.0 submission. eCTD v3.2.2 remains accepted during the optional-use period. esubmission.ema.europa.eu/
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EU eCTD v4.0 - EMA is planning to start the Pilot Phase 3 on Forward Compatibility for the Centrally Authorised Products in 2026. Further information and details how to participate will be published on the eSubmission website in Q1 2026. esubmission.ema.europa.eu/
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EU eCTD v4.0 - Validation criteria v1.1 - open for comments esubmission.ema.europa.eu/
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Just a reminder that from today, the updated EU M1 eCTD specification v3.1.1 and the related Validation Criteria v8.2 are in force. This is a non-technical update without impact on the EU regional DTD or stylesheet.
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A new version of the EU eCTD v4.0 controlled vocabularies is available, in Excel and xml format. Changes are highlighted in the Excel file, and marked with new/updated, accordingly. Previous versions of the EU controlled vocabularies are still valid esubmission.ema.europa.eu/
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EMA eCTD v4.0 technical pilot phase 2 update esubmission.ema.europa.eu/
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eCTD 3.2.2 - EU M1 v3.1.1 and Validation Criteria v8.2 accepted from 1st October esubmission.ema.europa.eu/
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