Biologe (Mikrobiologie, Genetik, Biochemie), promoviert.
Germany
Joined February 2010
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Michael Braun retweeted
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
Michael Braun retweeted
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…
Michael Braun retweeted
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/
Michael Braun retweeted
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/
Michael Braun retweeted
From September 1, 2025 the Danish Medicines Agency will request submission of bioequivalence data in CDISC format #eCTD
laegemiddelstyrelsen.dk/en/l…
Michael Braun retweeted
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/
Michael Braun retweeted
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/ps…
Michael Braun retweeted
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/eu…
Michael Braun retweeted
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/
Michael Braun retweeted
EU Harmonised technical eCTD guidance version 6.0 now available:
esubmission.ema.europa.eu/ec…
Release notes:
esubmission.ema.europa.eu/ec…
Michael Braun retweeted
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-informati…
Michael Braun retweeted
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/eC…
Michael Braun retweeted
Release of SG-HSA Specification Package v1.0 for Electronic Common Technical Document (#eCTD) Implementation in #Singapore
hsa.gov.sg/announcements/reg…
Michael Braun retweeted
FDA releases revision 8 of eCTD guidance; includes eCTD 4.0 specific information.
fda.gov/regulatory-informati…
Michael Braun retweeted
Italian AIFA post additional requirements for submitting eCTDs via the European CESP portal. These requirements will be mandatory effective August 20, 2024. Link:
aifa.gov.it/en/-/requisiti-a…
Michael Braun retweeted
Australian TGA has adopted the ICH Implementation Guide v1.5 for ICH eCTD v4.0. tga.gov.au/resources/resourc…
For implementation timeline, see here
tga.gov.au/tga-implementatio…
Michael Braun retweeted
Swissmedic pulishes eCTD 4.0 implementation guide package #eCTD
swissmedic.ch/swissmedic/en/…
Michael Braun retweeted
Proposed timeline for the implementation of #eCTD v4.0 in the EU esubmission.ema.europa.eu/eC…
