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Harmonised Technical Guidance for eCTD …

WEB2.2 Structure of Submissions. This document provides guidance on how to organise application information for electronic submission using the eCTD specifications. …

Actived: 9 days ago

URL: https://esubmission.ema.europa.eu/tiges/docs/eCTD%20Guidance%20v5.0_adopted%20version.pdf

eSubmission: Projects

WEBIn other words, an eCTD is the submission of PDF documents, stored in the eCTD directory structure, accessed through the XML backbone and with the files integrity guaranteed by …

Category:  Health Go Health

eCTD Guidance Document

WEBThis Guidance Document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic format to the National Competent …

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Harmonised Technical Guidance for Non-eCTD electronic …

WEBThis Guidance Document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic format to the National Competent …

Category:  Health Go Health

European Medicines Regulatory Network …

WEBThe eSubmission Roadmap is the strategic driver and reference that guides the alignment of priorities, resources and commitment put behind implementation for the achievement …

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European Medicines Regulatory Network …

WEB1. Executive Summary. The electronic Submission (eSubmission) Roadmap aims at establishing secure, consistent and efficient electronic submission processes for …

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Electronic Active Substance Master Files (eASMF)

WEBThe EMA eASMF submission rules are mandatory since 1st September 2013 and are applicable to all Centralised applications. The EU Assessment worksharing initiative is …

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EU Module 1 eCTD Specification

WEBCR 20110614 1.4.3 17 December 2012 EFPIA EFPIA changes, added PDF 1.5, 1.6, edited file allowed formats, added common for CP, adjustments to agency codes

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Practical Guidance For the Paper Submission of …

WEBPractical Guidance For the Paper Submission of Regulatory Information in Support of a Marketing Authorisation Application When Using the eCTD or NeeS as the Source …

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Harmonised Technical Guidance for eCTD …

WEBTypically, an eCTD application will cover all dosage forms and strengths of a product. In the centralised procedure, this will be equivalent to all dosage forms and strengths covered …

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eSubmission: TIGes Joint

WEBThe e-submission working group is a working group under the umbrella of the RSAC and consists of more than 10 participants from different members. The e-submission working group aims to inform EGA members of trends, developments and implications of any issues relating to electronic submissions impacting the generic pharmaceutical industry. AESGP.

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ASMF eCTD Guideline

WEBThis will serve as the basis for the initial approval in the new country and the future lifecycle management of the ASMF. According to the eCTD specification, the Module 1 eCTD …

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General FAQ relating to e-Submission for Veterinary …

WEBAn electronic submission (or e-submission) for a veterinary medicinal product is a submission of documents in relation to a marketing authorisation (application) to a …

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EU Change Control Process for Change Requests in the Entire …

WEBThis document establishes the change control process for EU eSubmission standards in the EEA, namely CR or Q&A referring to e.g. eCTD M1, eAF, EudraCT, RDM, Eudrapharm, etc., managed by the CCB. The purpose of the CCB is to accelerate decisions and results, improve the organisation and traceability of change requests, ensure follow-up of open

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EU Module 1 eCTD Specification

WEBThis document specifies Module 1 of the electronic Common Technical Document (eCTD) for the European Union (“EU”). This document should be read together with the ICH …

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eSubmission: VET eSub

WEBThe Veterinary Harmonisation Group (VHG) is a subgroup of the eSubmission expert group and is made up of representatives from National Competent Authorities, the EMA and …

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eSubmission: Projects

WEBThe electronic Application Form (eAF) and Product Management Service (PMS) teams would like to provide you with a comprehensive update on the progress of …

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Version 1.4.1 November 2011

WEBIn line with the general principles of the ICH eCTD Specification, it is intended that XML will eventually become the sole submission format for administrative forms and product …

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eSubmission: eAF

WEBThe word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised catalogue terms, built in business rule validation, and support for validation of form, etc. Implementation of mandatory use of the eAF is part of …

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