exalon

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

[exalon @ectdexperts]

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. https://t.co/VJ0ytKAENy

[exalon @ectdexperts]

EMA announces launch of eCTD v4.0 pilot phase III on forward compatibility for EU Centrally Authorised Products https://t.co/AlJQnBtz6n #eCTD4 #EMA #DrugRegulatory

[exalon @ectdexperts]

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 https://t.co/AlJQnBtz6n
#eCTDv4 #EMA

[exalon @ectdexperts]

Source: https://t.co/AlJQnBtz6n

RMS Service - Employee Center: https://t.co/B3yN0QfbUd

[exalon @ectdexperts]

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!

[exalon @ectdexperts]

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 https://t.co/ZJ7OLxoyVr

[exalon @ectdexperts]

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]

FDA, EMA officials encourage companies to pilot eCTD 4.0 https://t.co/2y1j5HORb1

[exalon @ectdexperts]

FDA, EMA officials encourage companies to pilot eCTD 4.0 https://t.co/2y1j5HORb1

[exalon @ectdexperts]

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!

[exalon @ectdexperts]

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. https://t.co/AlJQnBu6VV

[exalon @ectdexperts]

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.
https://t.co/AlJQnBu6VV

[exalon @ectdexperts]

EU eCTD v4.0 - Validation criteria v1.1 - open for comments
https://t.co/AlJQnBu6VV

[exalon @ectdexperts]

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.

[exalon @ectdexperts]

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
https://t.co/AlJQnBtz6n

[exalon @ectdexperts]

EMA eCTD v4.0 technical pilot phase 2 update
https://t.co/AlJQnBu6VV

[exalon @ectdexperts]

eCTD 3.2.2 - EU M1 v3.1.1 and Validation Criteria v8.2 accepted from 1st October
https://t.co/AlJQnBu6VV

[exalon @ectdexperts]

A new version of the EU eCTD v4.0 controlled vocabularies (v2) is now available, in excel (.xlsx) format, xml version to follow soon.
https://t.co/AlJQnBtz6n

[exalon @ectdexperts]

As of 1 September 2025, Marketing Authorisation Holders will no longer be able to create PSUR submissions if the primary contact indicated in the PSUR submission form does not have an IRIS account affiliated with the MAH of the product.
https://t.co/AlJQnBtz6n

[exalon @ectdexperts]

EU eCTD v4.0 validation criteria first version published. It complements the latest eCTD v4.0 ICH validation criteria and is currently focused on centrally authorised products. Further edits will include rules for MRP/DCP/NAPs.

https://t.co/AlJQnBtz6n

[exalon @ectdexperts]

From September 1, 2025 the Danish Medicines Agency will request submission of bioequivalence data in CDISC format #eCTD

https://t.co/Gj8IjU0ga5