TIGes will hold a Validation Webinar on 13th July 2012 (Friday)

TIGes Harmonization group scheduled Validation Webinar on 13^th July 2012 (Friday) to explain new EU validation criteria effective December 2012. 

TIGes will explain the changes in the new major versions of the EU validation criteria that will come into force the 1^st December 2012.

To find more information and registration please use the below mentioned weblink.

http://esubmission.ema.europa.eu/tiges/tigesdocuments.html

Irish Medicines Board (RB): Mandates Electronic Submissions

It was agreed by the Heads of Medicines Agencies (HMA) in Reykjavik on 28 February 2005 that by an agreed end-2009 deadline, the European regulatory agencies must have the infrastructure and processes in place to handle electronic-only eCTD submissions to successfully support the related decision-making processes for the authorisation of medicinal products within the European Union.

 

The IMB has fully adopted the European Guidance for eCTD (electronic Common Technical Document) and NeeS (Non-eCTD electronic submissions).   The transition to electronic submissions brings with it several advantages, not only the obvious reduction in printing, archiving and transportation costs, but also facilitates consistency in information viewed across agencies, the ability to manage the lifecycle of the product, and improved navigation and assessment of documentation. 

 

To find more information to use the below mentioned weblink

 

http://www.imb.ie/4910.htm?goback=.gde_833547_member_129165831

EMA advises sponsors to use the eSubmission Gateway during the Olympics

The Agency encourages applicants to connect to the eSubmission Gateway during the Olympic period, to allow for efficient and timely submission of their dossiers.

Companies can use the eSubmission Gateway to send centralized procedure submissions to the Agency in electronic common technical document (eCTD) format instead of sending CDs or DVDs via courier mail.

More information on the eSubmission Gateway and how to get connected is available under eSubmission Gateway

Source: http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/06/news_detail_001528.jsp&mid=WC0b01ac058004d5c1

Common Electronic Submissions Gateway (ESG) Work Plan for USFDA & Health Canada

Soon US FDA and Health Canada to share submissions gateway portal. 

The plan has been developed and implementation of this plan will help to submit Health Canada submissions by using current US FDA ESG gateway.

To find more information about this plan pleas use the below mentioned weblink.

http://www.actionplan.gc.ca/grfx/BAP-RCC/CESG_Reformat_Eng.pdf

EMA: VET eSubmission Updates

The following documents has been uploaded in the VET eSubmission webpage

Terms of Reference & E-submission Roadmap

http://esubmission.emea.europa.eu/tiges/vetesub.htm

1) Health Canada announced the finalization of the “Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format

1      Health Canada announced the finalization of the “Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format”

Notable point: HealthCanda said in a statement in April 212, “Health Canada is considering ending the Non-eCTD Hybrid Pilot at the end of March 2013 and would like to encourage sponsors to transition to the eCTD format as soon as possible to expedite the elimination of paper from the regulatory review process,”

In June 2012 Health Canada announced that the new Module 1 of the CTD will not be accepted in electronic form until fall 2012, there is no any detailed information about the full transition of eCTD.

To find more information please use the below mentioned weblink

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ctd_prep_nds-eng.php

EMA: Updated eSubmission Gateway Q&A document

EMA eSubmission Gateway: Questions and answers relating to practical and technical aspects of the implementation - Updated Documentation for production.

 

http://esubmission.ema.europa.eu/doc/Q%20&%20A%20for%20EMA%20eSubmission%20Gateway.pdf

CTD and eCTD: dossier preparation and submission - Basic seminar

The topics

    CTD and eCTD document structure in detail
    Special features of Module 1
    Module 2-5: Data quality, efficacy and safety
    From CTD to eCTD NeeS over - the most important stages
    eCTD: Submission and challenges in creating practical

Objectives

This course provides students with comprehensive knowledge base for the preparation and submission of registration dossiers. The first day focuses on the essential data. You will learn how data must be processed and where they are integrated into the CTD dossier.

The second day focuses on the dossier submission and provides a route of about Nees CTD to eCTD. You will receive information on structures, procedures and time frames and find out when a document "eCTD-ready". A Workshop on eCTD creation with lots of tips and tricks for practical implementation completes the program.


Contact person

Elsa Eckert
Conference Manager Pharmaceuticals

+49 6221 500-650

To find more information and Registration please use the below mentioned weblink

http://www.forum-institut.de/de/veranstaltungen/pharma-kosmetik-medizin/veranstaltung/details/1210262-ctd-ectd-dossiererstellung-und-einreichung/

Apex Regulatory's Blog: Using Reference Leafs in eCTD

One of my clients has recently asked me about the use of reference leafs in the eCTD and if you're not familiar with their use, they can seem pretty puzzling. So, I thought I'd write a (long overdue) post about the topic.

What are reference leafs?

For each PDF document submitted within an eCTD there is a corresponding XML leaf entry, with its own leaf id, title, checksum and operation.

http://apexregulatory.blogspot.sg/2012/06/using-reference-leafs-in-ectd.html

THE eCTD SUMMIT: PDF Update

Last month, I attended a conference focused on pharmaceutical regulatory writing and submissions in Baltimore, MD. During the two-day conference, a number of discussions and questions pertained to PDF files. As many of you may have similar questions or experiences, I wanted to share the questions and answers to provide some greater insight into PDFs in relation to electronic submissions.

Q: What versions of PDF’s are acceptable?

 
A: The FDA updated their PDF Specification in December 2011 to allow PDF versions 1.4 through 1.7. The ICH recently discussed this specification, and agreed to accept version 1.7 and will soon issue new standards.

Q: Do I need to upgrade my PDFs to the current version 1.7?

 
A: No. The specifications for PDFs are backward inclusive. This means that the PDF 1.7 specification includes all of the functionality previously documented in the Adobe PDF Specifications for versions 1.0 through 1.6.

To find more information please use the below mentioned weblink 

http://theectdsummit.com/?p=2061

 

 

US FDA: New version of congressional bill S. 3187 with mandatory Electronic Regulatory Submissions (eCTD) provision

New version of congressional bill S. 3187 with mandatory Electronic Regulatory Submissions (eCTD) provision.

Discussed in the SEC. 1136. ELECTRONIC SUBMISSION OF APPLICATIONS. page no 350 of the document.

Please use the below mentioned weblink to review or download the PDF copy of the bill.

http://republicans.energycommerce.house.gov/Media/file/PDFs/BILLS-112s3187-SUS.pdf