Regulators Discuss Best Practices for EMA eCTD Submissions
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
- (correct use of application number in PA submissions, related sequence, submission description)
- Not always sufficiently clear which regulatory activity a submission belongs to
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
Note: this list is not exhaustive, if in doubt about any aspect of eCTD use, ask EMEA.