Últimas noticias

DADI Project update now available

agosto 10th, 2021|0 Comments

DADI project update is now available. This update includes a timeline for the first forms to be released, a list of features of the human variation form and an updated questions & answers document.

Updated release schedule for eAF now available Call for volunteers for eAF v1.25.0.0 (reflecting the updated Medical Devices regulation) Updated technical documents for eAF v1.25.0.0 now available

agosto 2nd, 2021|0 Comments

An updated release schedule for the electronic Application Forms (eAF) is now available. The version 1.25.0.0 of the electronic Application Forms (eAFs) is planned for release at the end of September 2021 with a short [...]

Mandatory use of OMS in eAF for all submissions to EMA

julio 12th, 2021|0 Comments

The EMA would like to inform applicants and Marketing Authorisation Holders (MAHs) that as part of the development of the Substance, Product, Organisation and Referential (SPOR) data management services, and in anticipation to the upcoming [...]

Mandatory use of OMS in eAF for all CAP submissions

julio 12th, 2021|0 Comments

The EMA would like to inform applicants and Marketing Authorisation Holders (MAHs) that as part of the development of the Substance, Product, Organisation and Referential (SPOR) data management services, and in anticipation to the upcoming [...]

Digital Application Dataset Integration (DADI) project

marzo 25th, 2021|0 Comments

The European Medicines Regulatory Network has launched a new telematics project called the Digital Application Dataset Integration project (DADI) to modernise and improve use of the EU electronic Application Forms (eAFs). DADI has been established [...]

Introduction

marzo 25th, 2021|0 Comments

The Digital Application Dataset Integration (DADI) project will replace the current PDF-file based electronic application forms (eAFs), making the future form-filling and submission handling process more efficient. The new web-based system will be aligned with [...]

Updated eCTD EU M1 specification now available

marzo 12th, 2021|0 Comments

The eCTD EU Module 1 specification has been updated. The updated EU M1 spec v3.0.4 and the related release notes are available here. There are no changes to the DTD and hence this version enters [...]

Updated EU M1 eCTD Specification

marzo 12th, 2021|0 Comments

The EU eCTD Module 1 Specification has been updated to reflect clarifications and the updated version 3.0.4 is available for immediate use. Release notes with practical information on changes are provided below. There are no [...]