IPI - Editorial

IPI
• Using MS Word templates designed for
eCTD compliance
• Styling the document using Heading 1
through 9 and Captions
• Using MS Word properly – building tables
of contents, tables of figures and tables,
inserting hyperlinks or cross-references
when referring to related content
• Configuring PDFMaker, Distiller or PDF
rendering engines to create compliant
output
• Be aware of the recommended
configurations of resolution and colour
when scanning documents
These requirements apply not just to internal
authors and regulatory operations staff, but
should be made part of standard
deliverables from contract writers, contract
research organisations, and other outside
suppliers.
Correct preparation of PDF files for eCTD
submissions ensures that the review starts
on time and enables the review to be
conducted with the support of the electronic
navigation aids that are so critical to the
review experience.
3 FDA ELECTRONIC SUBMISSION
GATEWAY
FDA has implemented the Electronic
Submission Gateway (FDA ESG) to enable
sponsors to send information electronically
to the FDA. It has been implemented using
a software application certified to comply
with secure messaging standards . The FDA
Centers accepting submission via the ESG
are listed in Table 1, along with the
submission types that may be submitted via
the ESG.
FDA has made usage of the ESG
inexpensive, requiring only digital certificates
at the cost of US$20 per user per year, and
an easy-to-follow process for registering for
a test account and performing three test
transmissions in order to qualify for a
production account.
EMEA and other health authorities
around the world who accept electronic
submissions have not implemented a similar
capability for electronic transmission of
regulatory communication, except for
adverse event reports in the European
Union.
4 CONCLUSION
Great strides have been made by the
regulatory authorities in the US and EMEA to
prepare their technical infrastructures for
eCTD. Further announcements and
clarification of intent to mandate electronic
submissions are expected in 2008, with
regular updates planned for this journal ■
Antoinette Azevedo founded e-Submissions
Solutions.com (a California corporation) to
advise all sizes of
biotechnology and
pharmaceutical
companies on the use
of technology to
manage regulatory
documents and
publish electronic
submissions. Her experience ranges from
developing strategies for document
management and electronic publishing, to
implementation of fully-validated systems,
and production of paper and electronic
submissions accepted for review by
regulatory authorities worldwide.
Email: AAzevedo@e-Submissions
Solutions.com
References
1 Guidance for Industry: Providing
Regulatory Submission in Electronic
Format—NDA, U.S. Department of Health
and Human Services, Food and Drug
Administration, Center for Drug Evaluation
and Research (CDER), January 1999.
2 Guidance for Industry: Providing
Regulatory Submission in Electronic
Format—General Considerations, U.S.
Department of Health and Human
Services, Food and Drug Administration,
Center for Drug Evaluation and Research
(CDER), Center for Biologic Evaluation and
Research (CBER), January 1999.
3 Guidance for Industry: Providing
Regulatory Submissions in Electronic
Format —Content of Labeling, Food and
Drug Administration, Center for Drug
Evaluation and Research (CDER), Center
for Biologic Evaluation and Research
(CBER), April 2005.
4 Guidance for Industry: Providing
Regulatory Submissions in Electronic
Format —Human Pharmaceutical Product
Applications and Related Submissions
Using the eCTD Specifications, Center for
Drug Evaluation and Research (CDER),
Center for Biologic Evaluation and
Research (CBER), April 2006.
5 Guidance for Industry: Providing
Regulatory Submissions in Electronic
Format — Drug Establishment and Drug
Listing, U.S. Department of Health and
Human Services, Food and Drug
Administration, Office of the Commissioner,
July 2008.
6 Guidance on Providing Regulatory
Submissions in Electronic Format:
Withdrawal of Guidances, [Docket Nos.
1999D-0054, 2001D-0475, and 2003D-
0364] (formerly Docket Nos. 99D-0054,
01D-0475, and 03D-0364, respectively)
U.S. Department of Health and Human
Services, Food and Drug Administration,
7 EMEA Implementation of Electronic-Only
Submission and eCTD Submission:
Practical Guidelines Relating to Non-eCTD
Electronic Submissions, London, 1
November 2008, EMEA/633919/2008 v1.0.
8 EMEA Implementation of Electronic-Only
Submission and Mandatory eCTD
Submissions in the Centralised Procedure:
Statement of Intent, London, December
2008, EMEA/572459/2008.
9 Regulated Product Submission, U.S.
National Institutes of Health, National
Cancer Institute, www.
gforge.nci.nih.gov/plugins/wiki/index.php?
Regulated%20Product%20Submission&id
=234&type=g
10 Portable Document Format
Specifications, U.S. Department of Health
and Human Services, Food and Drug
Administration, Center for Drug Evaluation
and Research (CDER), Center for Biologic
Evaluation and Research (CBER), version
2.0, 2008-06-04.
11 EMEA Implementation of Electronic-Only
Submission and eCTD Submission:
Questions and Answers Relating to
Practical and Technical Aspects of the
Implementation, London, December
2008, EMEA/596881/2007, v0.5.
12 FDA Electronic Submission Gateway (ESG),
http://www.fda.gov/esg/, FDA Industry
Systems Website Staff, May 1, 2008.
13 FDA Electronic Submissions Gateway,
Submission Types Supported by the FDA
ESG,www.fda.gov/esg/userguide/WebHel
p/AS2_Routing_IDs.htm#figure7http://ww
w.fda.gov/esg/, FDA Industry Systems
Website Staff, May 1, 2008.
14 FDA Electronic Submissions Gateway,
Submission
Statistics,
http://www.fda.gov/esg/submission_stats
.htm , FDA Industry Systems Website
Staff, May 1, 2008.
36 IPI