eCTD Guidance Document - eSubmission - Europa

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1. INTRODUCTION In 2005 the Heads of Medicines Agencies agreed that all Member States would be able to accept eCTD (electronic Common Technical Document) applications, without accompanying paper copies, by the end of 2009. The benefits of moving to e-working are considered to be: • Reduction in administrative overheads from less paper movement, • Reduction of physical archiving space, • Facilitation of the review process. This Guidance Document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic format to the National Competent Authorities (hereinafter referred to as NCAs) and the European Medicines Agency (hereinafter referred to as EMEA). This document details the requirements for the submission of eCTD electronic submissions. A separate document, covering NeeS (Non-eCTD electronic Submissions), has already been published on the EMEA’s eSubmission website and is available via this link. This document has been created by the eGuidance Topic Group, a sub-group of the Telematics Implementation Group – Electronic Submissions (TIGes), consisting of agency representatives from Belgium, Denmark, EMEA, France, Germany, Hungary, The Netherlands, Portugal, Sweden and the United Kingdom, together with industry representatives from EFPIA and EGA. It has also been endorsed by the TIGes. National Competent Authorities have been strongly recommended to adopt this guidance as the basis for their dealings with applicants. It should be stressed that this Guidance Document reflects the current situation and will be regularly updated in the light of changes in national and/or European legislation together with further experience gained within NCAs and the EMEA of using information submitted in electronic format. It should be emphasised that eCTD applications should now be regarded as the principal submission format in the EU. This document assumes a certain basic understanding of eCTD applications. A list of background publications can be found in Annex 1. Applicants should pay special attention to the recommendations of the ICH M2 Expert Working Group on the eCTD and the TIGes in the EU. Consolidated specifications can also be found on the Commission Eudralex website. International standards development through ICH, ISO and HL7 will eventually lead to the eCTD becoming part of a wider group of regulated product submissions, covering medical devices, veterinary products and food additives as well as medicinal products. This Guidance Document consists of four parts: Introduction, General Considerations, Module Specific Information and Advice on Specific Application Types together with associated annexes. In addition please refer to Chapter 7 of the Notice to Applicants, Volume 2A for specific NCA requirements. Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD Applications Version: 1.0 May 2009 Page 4 of 41
A brief glossary of terms (for the purpose of this document only) is indicated below: Term Definition Applicant A pharmaceutical company or its agent that is submitting information in support of an application. Applicant’s information Regulatory information submitted by an applicant for, or to maintain, a marketing authorisation that falls within the scope of this guidance document. eCTD application A collection of electronic documents compiled by a pharmaceutical company or its agent in compliance with European legislation and guidelines in order to seek a marketing authorisation or any amendments thereof. An eCTD application may comprise a number of sequences. In the EU an eCTD application may comprise several dosage forms and strengths, all under one invented product name. This is understood to be equivalent to a Global Marketing Authorisation according to Art. 6 para 2 Dir. 2001/83/EC as amended. Some review tools describe such a collection as a dossier. Procedure A Community registration procedure for the authorisation of medicinal products in the European Community. There are 4 types of procedure that operate within the EC – Centralised, Decentralised, Mutual Recognition and National. Submission or Sequence A single set of information and/or electronic documents supplied at one particular time by the applicant as a part of, or the complete, eCTD Application. In the context of eCTD, this is equivalent to a sequence. Regulatory activity A collection of sequences covering the start to the end of a specific business process, e.g. an initial MA application or Type II variation. It is a concept used in some review tools to group together several business related sequences. Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD Applications Version: 1.0 May 2009 Page 5 of 41
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Page 3: Table of Contents 1. INTRODUCTION .
Page 7 and 8: Please check for specific NCA guida
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Page 27 and 28: Annex 3 Guidance and Best Practice
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