The eCTD summit

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

Sounds like EMEA stayed busy through the holiday season as they posted four new or updated guidance documents at the end of December. Most significantly, EMEA implementation of electronic-only submissions and mandatory eCTD submissions in the centralised procedure: Statement of Intent tells us:

“From 1 January 2010, the EMEA will mandate the use of the eCTD format for all electronic-only submissions for all applications (new and existing) and all submission types. Rapporteurs and CHMP members will not receive paper copies or other electronic formats.”

As with the rest of the EMEA’s statements and guidelines pertaining to eCTD, this only applies to the Centralised Procedure.

A “matching” statement of intent for non-eCTD electronic submissions tells of the retirement of NeeS. It also announces the introduction of a set of specific guidelines on submission structure, format and presentation, which non-eCTD submissions should adhere to for the centralised procedure from 1 February 2009 until such time as the eCTD format is mandatory. These guidelines are found in EMEA implementation of electronic-only submissions eCTD submission: Practical guidelines relating to Non-eCTD submissions.

Finally, the highly useful document EMEA Implementation of Electronic Submissions and eCTD Submissions Statement of Intent Q&A Relating to Practical and Technical Aspects has been re-issued. Changes are minor and include asking for virus checking information in the cover letter instead of a reviewer guide, and acknowledging a discrepancy between the eCTD file naming
convention and the PDF file naming requirements for EPAR (product information) documents (you are advised to use eCTD file naming conventions for the time being).

My collegue discussed this announcement with EMEA representatives this week, and they have indicated that although they are not in a legal position to require electronic submissions, they strongly recommend against paper submissions.

(P.S. After an internal struggle, I suppressed the urge to label this post “It’s Been NeeS”.)

As the EU authorities continue their progress towards welcoming eSubmissions, information continues to surface on their web sites and elsewhere.

The Swedish National Authority (MPA) has updated their web site with new eSubmission information – see Electronic submissions to the MPA. The MPA maintains a dedicated email address (eSubmissions@mpa.se) for general questions on electronic submissions. They also provide guidance on media, cover letters, handling of MS Word documents, etc. Some of the information is only in Swedish (which BabelFish unfortunately won’t translate!).

If you visit the web site of the Spanish agency La Agencia Española de Medicamentos y Productos Sanitarios, look for a Welcome link in the top toolbar to access some content in English. Click the Electronic Submission link and look for the link to Instructions for electronic submission eCTD/NEES Pilot Phase. The agency has instructions for generating electronic submissions, to take effect in January 2009. The agency requuires sponsors to register new authorizations and variations in the AEMPS Regulatory Tool: RAEFAR, and to use the Belgian tool eCTDchecker on NEES submissions. A more detailed guide is available in Spanish: Guide AEMPS v1.11 .

Finally, an interesting presentation on Electronic Submissions in Hungary, by Dr. Gergely Zajzon of National Institute of Pharmacy is available. Since 2006, the National Institute of Pharmacy (OGYI) in Hungary has been accepting full electronic eCTD applications, without any printed sections of the dossier. Dr. Zajzon’s presentation discusses status, progress, challenges, requirements for eCTD and NEES in Hungary, and the agency’s ongoing program to digitize paper submissions.