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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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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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. esubmission.ema.europa.eu
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. esubmission.ema.europa.eu
From September 1, 2025 the Danish Medicines Agency will request submission of bioequivalence data in CDISC format #eCTD laegemiddelstyrelsen.dk/en/licensing/l…
eCTD in Ukraine – A key step towards the digitalisation of regulatory processes in healthcare eba.com.ua/en/ectd-vazhly…
Important notification from EU EMA regarding a planned maintenance of the PSUR repository systems: The system will be offline 20-22 June. To avoid delays, PSUR packages should be submitted a few days before. esubmission.ema.europa.eu/psur/psur_repo…
Minor update to the EU eCTD M1 specifications released (v.3.1.1) together with release notes, updated eCTD validation criteria and updated CMB harmonized guidance for #eCTD. esubmission.ema.europa.eu/eumodule1/inde…
The WHO Prequalification Unit is pleased to announce the opening of the ePQS portal to external users extranet.who.int/prequal/news/w…
Validation of eCTDs using the EU M1 specification 3.1 for CEP applications can cause problems - statement from EDQM: edqm.eu/en/-/validatio…
Ukraine is switching to the international electronic standard eCTD for drug registration e-news.com.ua/show/581254.ht…
ICH releases overhauled stability guideline for consultation raps.org/news-and-artic…
EMA announces production go-live for submissions of human variations web-based eAFs (electronic Application Forms) for non-CAPs (MRP/DCP/national). esubmission.ema.europa.eu
EU EMA: The Product Management Service (PMS) User Interface (PUI) edit functionalities are now available for Industry users on the Product Lifecycle Management (PLM) portal. esubmission.ema.europa.eu
eCTD 3.2.2 - validation criteria 8.1 to be updated esubmission.ema.europa.eu
An updated version of the EU eCTD v4.0 Controlled Vocabularies is now available esubmission.ema.europa.eu/eCTD%20NMV/EU%…
The European Shortages Monitoring Platform (ESMP) is officially live for routine shortage reporting by marketing authorisation holders esmp.ema.europa.eu
EU eCTD v4.0 Controlled Vocabularies in .xml format now available. The package includes genericode (.xml) format for the first version of the EU eCTD v4.0 Controlled Vocabularies. They are complementing the .xlsx version which was published in October. esubmission.ema.europa.eu
EU Harmonised technical eCTD guidance version 6.0 now available: esubmission.ema.europa.eu/ectd/docs/Harm… Release notes: esubmission.ema.europa.eu/ectd/docs/Rele…
Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry fda.gov/regulatory-inf…
EMA: Call for Interest eCTD v4.0 Technical Pilot; invitation for interested eCTD tool vendors to participate in Step 1. For details check esubmission.ema.europa.eu/eCTD%20NMV/eCT…
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