1. FDA Experience with eCTD
Gary M Gensinger
Director, Regulatory Review Support Staff
Office of Business Process Support
Center for Drug Evaluation and Research

2. eCTD Submissions (as of September 18, 2007)
Application
Count
Submissions
IND
462
7,694
NDA
247
3,653
ANDA
295
981
BLA 48
1,669
DMF
101
132
FDA Internal
154
243
Total
1,310
14,372

4. Who’s Submitting 184 Unique Sponsors…Maybe Much Inconsistency
Acme Group Limited
Acme Group Limited d/b/a Acme
Acme Group Limited dba Acme
Acme Group Limited, dba Acme
AcmePharmaceuticals
AcmePharmaceuticals, S. A. d/b/a Acme
AcmePharmaceuticals, S.A. d/b/a Acme
AcmePharmaceuticals, S.A. dba Acme

5. Withdrawal of Guidance
Waiver policy awaiting posting
Blanket exceptions include
Mid-cycle cutovers to new format
Relaxation of once eCTD always eCTD for paper filers who submit
Labeling
Carcinogenicity datasets to INDs
Will be found in Electronic Submission Docket

6. eCTD Pilot Process No-Risk way to validate your eCTD understanding
Continuing to receive pilot submissions
Pilot submission evaluated for technical compliance only unless directed otherwise
Accepting all submission types, e.g., IND, NDA, Amendments, Master Files, Annual Reports…
Generally not required if using experienced submission publisher

7. Electronic Submission Gateway
Critical to Improving Efficiency
Gets your material to the reviewer in an expedited manner
Introduces automation into FDA Processes
Use of electronically fillable forms key
Move validation into the forefront

8. Validation FDA finalizing its eCTD Validation Specification
Not currently being applied
ESG Requirements re: file/folder naming
Spaces and special characters not allowed
Consistency Checking
application-type="nda“ but 1571 form submitted
<application-number>919297</application-number> but form says

9. Gary Gensinger gary.gensinger@fda.hhs.gov 301.796.0589