EMEA-EFPIA Information Day 2009 and eCTD/NeeS (Part 1)

EMEA-EFPIA Information Day 2009, which was held on 24 February 2009 in London, included several interesting presentations about eCTD and NeeS. 

Claire Holmes of EMEA presented on eCTD/Non eCTD electronic Submission (Nees): impact on the centralised procedure.  Ms. Holmes explained the background of the recent announcement about mandatory eCTD: based on legal advice from EMEA, instruction was given that although eSubmissions cannot be mandated for the Centralised Procedure due to lack of legislative basis, it is possible to mandate the format of the eSubmission if received.  Thus, the recent milestone of requiring all eSubmissions to be eCTDs by 1 January 2010.  After that date, non-eCTD format electronic submissions will be rejected.  Paper-only submissions will continue to be accepted, but will lead to handling and review issues as EMEA processes are being engineered for eSubmissions. 

The number of eCTDs received has been increasing exponentially at EMEA (988 eCTD sequences since 1 July 2008).  Around one-third of eSubmissions in recent months have been eCTDs.  Although the majority of eCTDs are still new applications, an increasing number of converted “baselines” has been seen in the last six months.   

There’s lots more in the presentation, especially concerning NeeS, but I’ll wrap up for today by repeating Ms. Holme’s Key Messages for Industry: 

  • Concern at EMEA that the majority of electronic/eCTD applications are STILL accompanied by a paper copy – this is disposed of on receipt by EMEA
  • Many companies receiving requests for paper from NCAs – please do not provide paper but instead contact EMEA for guidance and resolution
  • Limit submissions to one per CD/DVD, clearly labelled
  • Send DVD in place of multiple CDs (multiple CDs lead to handling difficulties
  • Companies should refer to the EMEA‘s practical guidance for detailed information on presentation and structure of the eCTD
  • Envelope meta-data still not used as effectively/consistently as desired by EMEA –  particularly the submission description
  • Not always sufficiently clear which regulatory activity a submission belongs to (correct use of application number in PA submissions, related sequence, submission description)
  • Information relating to multiple regulatory activities should not be combined within a single eCTD submission (applies particularly to FUMs/SOs/PSUR – we have seen several submissions that combine all these into one sequence)
  • EU M1 V1.3 must be used for all applications
  • List not exhaustive… if in doubt about any aspect of eCTD use, ask EMEA

 

Article written by

I am GlobalSubmit’s director of professional services. My area of expertise is electronic document management and regulatory submissions, specifically eCTD. I have 12 years of biopharmaceutical industry experience in the US, Europe, Israel and Japan, concentrating on content management for Regulatory Affairs & Submissions, Clinical Development, and Manufacturing, and in submission assembly and publishing. I have worked with over 50 pharmaceutical clients. Previously, I was the practice lead for the Subject Matter Experts/Business Analysts group at First Consulting Group (FCG), now part of CSC. I supervised a group of 12 SMEs/BAs. I was instrumental in the development of the FirstDoc® suite. I developed the project delivery methodology for FirstDoc® R&D, including training materials, project plans, workshop methodology and materials, and requirements and design specifications. I managed the design and development of FirstDoc® GMP and FirstDoc® Legal. Please feel free to contact me at kathleen.clark@globalsubmit.com if you are interested in talking about eCTD products or consulting services, or if you have ideas for the blog.

One Response

Page 1 of 1
  1. Shakul Hameed
    Shakul Hameed March 25, 2009 at 10:09 AM | |

    As for as Holems presentation is conerned

    I have some doubts

    1) If the application is in centralised procedure there is no need of eCTD. Then when EMEA will going to manadate eCTD format in centaralised procedure?

    2)After the manadate of eCTD(1 January 2010) EMEA will going to reject non-eCTD format. After that EMEA will continue accept Paper submissions only. How long they will going to accept Paper submissons ?

    3) If the EMEA keep on accepting Paper submissions after 2010 the companies will prefer to go for paper submissions.

    3)It is good to heared news from EMEA about around one third of eSubmissions in recent months have been eCTDs format only.

Please comment with your real name using good manners.

Leave a Reply

You must be logged in to post a comment.