exalon @ectdexperts
Latest news from Exalon and updates from Regulators, Pharmaceutical Industry and other Stakeholders. exalon.com Radolfzell (Germany) Joined March 2010-
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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
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/cessp/cessp.htm
FDA issues Draft Guidance on Container Closure Systems for Human Drugs and Biological Products fda.gov/regulatory-inf…
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/…
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
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
Source: esubmission.ema.europa.eu RMS Service - Employee Center: support.ema.europa.eu
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!
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-artic…
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
FDA, EMA officials encourage companies to pilot eCTD 4.0 raps.org/news-and-artic…
FDA, EMA officials encourage companies to pilot eCTD 4.0 raps.org/news-and-artic…
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!
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
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
EU eCTD v4.0 - Validation criteria v1.1 - open for comments esubmission.ema.europa.eu
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.
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
EMA eCTD v4.0 technical pilot phase 2 update esubmission.ema.europa.eu
eCTD 3.2.2 - EU M1 v3.1.1 and Validation Criteria v8.2 accepted from 1st October esubmission.ema.europa.eu
A new version of the EU eCTD v4.0 controlled vocabularies (v2) is now available, in excel (.xlsx) format, xml version to follow soon. esubmission.ema.europa.eu
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Liming G. @pharma_ai_g
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Pharma-Zeitung.de @pharmazeitung
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Pharma Guy @pharmaguy
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Liming G. @pharma_ai_g
9 Followers 42 Following AI+Regulatory Submission=Smarter, Faster Compliance - AI-assisted reg doc authoring - Auotmated eCTD compiling & publishing - eCTDv4.0 transition and adoption
PharmaRegAfriSummit @AfriReg
140 Followers 170 Following PharmaReg AfriSummit aims to provide a strategic platform for pharmaceutical regulatory experts and industry professionals in Africa.
Certara @Certara
2K Followers 540 Following Accelerating medicines to patients with biosimulation, technology and services.
Drug Information Asso... @DrugInfoAssn
207 Followers 44 Following DIA is the leading global multidisciplinary life science membership association. Together we accelerate health innovation for all.
Fermat's Library @fermatslibrary
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Weave Bio @weave_bio
153 Followers 132 Following Weave Bio brings data, content, and workflows together to support regulatory content and lifecycle management across drug development.
Jason Kalkirtz, Esq. @JasonKalkirtz
1K Followers 5K Following FDA & FTC Attorney (JD/LLM/MBA) Regulatory/Compliance matters involving the food, dietary supplement, drug, medical device & cosmetic industries. RT≠Endorsement
Mono eCTD Office @ectdoffice
177 Followers 17 Following Suite of integrated software products for the creation, manipulation, validation, publishing and viewing of NeeS / VNeeS / eCTD electronic submissions.
Veeva Systems @veevasystems
6K Followers 131 Following Veeva Systems is a leader in cloud-based business solutions for the global life sciences industry.
Freyr Solutions @FreyrSolutions
381 Followers 48 Following Freyr Solutions is the largest global, Regulatory solutions and services company for the Life Sciences industry.
EXTEDO @EXTEDO
364 Followers 10 Following EXTEDO is the key software and service solutions provider in the field of eCTD and Regulatory Information Management. Imprint: https://t.co/jvPGM8HzRz
Calyx @calyxai
194 Followers 49 Following Calyx is the leading provider of Medical Imaging, eClinical, and Regulatory solutions and services to solve complex challenges in clinical research.
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CDISC @CDISC
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FiercePharma @FiercePharma
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Health @health
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pharmalot @pharmalot
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EFPIA @EFPIA
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The Pharma Letter @ThePharmaLetter
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