ECTD Tech Guide v1.1
ECTD Tech Guide v1.1
ECTD Tech Guide v1.1
Guidance for Industry Providing Regulatory Submissions in Electronic Format Certain Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications
September 2016
eCTD
TECHNICAL CONFORMANCE GUIDE
September 2016
REVISION HISTORY
DATE VERSION SUMMARY OF REVISIONS
October 2015 1.0 Initial Version
Updated/Clarified following sections:
Section 2.3 (Transitioning to eCTD Format and Resubmission of Non- eCTD
Documents), and subsections 2.3.1, 2.3.2, 2.3.3, 2.3.4
Section 2.4 (eCTD Leaf Titles)
Section 2.6 (Presubmissions)
Section 2.7 (Rolling Submission)
Section 3.1.2 (Cover Letter and Reviewers Guide)
Section 3.1.7 (Information Amendments)
Section 3.1.8 (Letters of Authorization)
September 2016 1.1 Section 3.1.9 (Field Copy Certification)
Section 3.5.2 (Study Reports)
Section 4.1 (Combining Multiple 3.2.S or 3.2.P Sections with Similar Metadata)
Section 5.0 (Combination Products)
References
Removed section:
Section 3.3.4 (Datasets)
Added sections:
Section 2.3.4 (Resubmission of non-eCTD documents )
Section 3.1.5.3 (Websites, Electronic Interactive Programs, and Electronic Detail Aids)
Table of Contents
1. INTRODUCTION ..................................................................................................................................1
1.1 BACKGROUND .......................................................................................................................................... 1
1.2 PURPOSE ................................................................................................................................................. 1
1.3 DOCUMENT REVISION AND CONTROL ............................................................................................................ 2
1.4 RELATIONSHIP TO OTHER DOCUMENTS ......................................................................................................... 2
2. GENERAL CONSIDERATIONS................................................................................................................2
2.1 ECTD PUBLISHING..................................................................................................................................... 2
2.2 ECTD SAMPLES ........................................................................................................................................ 2
2.3 TRANSITIONING TO ECTD FORMAT AND RESUBMISSION OF NON-ECTD DOCUMENTS ............................................ 2
2.3.1 Transitioning from Paper to eCTD using us-regional v2.01 ........................................................ 3
2.3.2 Transitioning from Paper to eCTD using us-regional v3.3 .......................................................... 3
2.3.3 Transitioning from us-regional v2.01 to us-regional v3.3 ........................................................... 3
2.3.4 Resubmission of non-eCTD documents ....................................................................................... 3
2.4 ECTD LEAF TITLES ..................................................................................................................................... 4
2.5 ECTD LIFE CYCLE ...................................................................................................................................... 4
2.6 PRESUBMISSIONS ...................................................................................................................................... 5
2.7 ROLLING SUBMISSIONS............................................................................................................................... 5
2.8 STUDY TAGGING FILES................................................................................................................................ 5
3. ORGANIZATION OF THE ECTD .............................................................................................................6
3.1 MODULE 1 ADMINISTRATIVE INFORMATION AND PRESCRIBING INFORMATION ................................................... 6
3.1.1 FDA Regional eCTD Backbone Files ............................................................................................. 6
3.1.2 Cover Letter and Reviewers Guide ............................................................................................. 6
3.1.3 Cross Referencing Previously Submitted Information that is not in eCTD Format ...................... 7
3.1.4 Labeling ...................................................................................................................................... 7
3.1.5 Advertisements and Promotional Labeling Material .................................................................. 8
3.1.5.1 Advertisements and Promotional Labeling to CDER ........................................................................ 8
3.1.5.2 Advertisements and Promotional Labeling to CBER ........................................................................ 8
3.1.5.2.1 Using version 2.01 of the us-regional.xml file ............................................................................. 8
3.1.5.2.2 Using version 3.3 of the us-regional.xml file ............................................................................... 8
3.1.5.3 Websites, Electronic Interactive Programs, and Electronic Detail Aids............................................ 8
3.1.6 Marketing Annual Reports .......................................................................................................... 9
3.1.7 Information Amendments........................................................................................................... 9
3.1.8 Letters of Authorization .............................................................................................................. 9
3.1.9 Field Copy Certification ............................................................................................................. 10
3.2 MODULE 2 SUMMARIES ........................................................................................................................ 10
3.2.1 Bioequivalence Summary Tables .............................................................................................. 10
3.3 MODULE 3 QUALITY ............................................................................................................................. 10
3.3.1 Lot Distribution Data ................................................................................................................ 10
3.3.2 Literature References ................................................................................................................ 10
3.4 MODULE 4 NONCLINICAL ....................................................................................................................... 10
3.4.1 Study Reports ............................................................................................................................ 10
3.4.2 Literature References ................................................................................................................ 11
3.4.3 Datasets .................................................................................................................................... 11
3.5 MODULE 5 CLINICAL ............................................................................................................................. 11
3.5.1 Tabular Listing of All Clinical Studies ........................................................................................ 12
3.5.2 Study Reports ............................................................................................................................ 12
3.5.3 Case Report Forms (CRFs) ......................................................................................................... 12
3.5.4 Periodic Safety Reports ............................................................................................................. 13
3.5.5 IND Safety Reports .................................................................................................................... 13
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3.5.6 Literature References ................................................................................................................ 13
3.5.7 Datasets .................................................................................................................................... 14
4. ISSUES AND SOLUTIONS.................................................................................................................... 14
4.1 ISSUE: COMBINING MULTIPLE 3.2.S OR 3.2.P SECTIONS WITH SIMILAR METADATA ........................................... 14
4.2 ISSUE: CLINICAL STUDY REPORT SUBMITTED IN INCORRECT SECTION ................................................................. 14
4.3 ISSUE: NOT APPLICABLE (N/A) OR UNASSIGNED FOLDERS IN MODULE 4 OR 5 .................................................... 15
4.4 ISSUE: MULTIPLE SIMILAR STF STRUCTURES DISPLAYING IN MODULE 4 OR 5 ..................................................... 15
5. COMBINATION PRODUCTS ............................................................................................................... 15
REFERENCES ............................................................................................................................................... 20
RELATED REFERENCES ................................................................................................................................ 21
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1. Introduction
1.1 Background
This eCTD Technical Conformance Guide (Guide) provides specifications,
recommendations, and general considerations on how to submit electronic Common
Technical Document (eCTD)-based electronic submissions to the Center for Drug
Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research
(CBER). The Guide supplements the guidance for industry Providing Regulatory
Submissions in Electronic Format Certain Human Pharmaceutical Product
Applications and Related Submissions Using the eCTD Specifications (eCTD Guidance). 1
The eCTD Guidance implements the electronic submission requirements of section
745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to
electronic submissions for certain investigational new drug applications (INDs); new
drug applications (NDAs); abbreviated new drug applications (ANDAs); certain
biologics license applications (BLAs); and master files submitted to CDER or CBER.
These submissions may apply to combination products with CDER or CBER as the lead
center. 2
1.2 Purpose
This Guide provides technical recommendations to sponsors and applicants for the
standardized electronic submission format of INDs, NDAs, ANDAs, BLAs, and master
files. The Guide is intended to complement and promote interactions between sponsors
and applicants and FDAs electronic submission support staff. However, it is not
intended to replace the need for sponsors and applicants to communicate directly with
support staff regarding implementation approaches or issues relating to electronic
submissions.
Because of the inherent variability across studies and applications, it is difficult to
identify all issues that may occur related to the preparation and transmission of electronic
submissions. Therefore, prior to submission, sponsors and applicants should discuss
questions with the appropriate centers electronic submission support staff within the
appropriate center CDER: [email protected] or CBER: [email protected].
1
A link to this document can be found at http://www.fda.gov/ectd
2
See 21 CFR Part 3. Combination products are comprised of any combination of a drug and a medical
device; a medical device and a biological product; a biological product and a drug; or a drug, a medical
device, and a biological product. Combination products are assigned to a lead center for review; see 21
CFR 3.4.
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2. General Considerations
2.1 eCTD Publishing
Submissions in the eCTD format should be created following all applicable guidances
and specifications available on our eCTD Web page under eCTD Documentation and
Resources:
http://www.fda.gov/ectd.
2.2 eCTD Samples
Samples of eCTDs can be submitted for feedback on document placement, navigation,
and effective use of metadata and Study Tagging Files (STFs). For eCTD samples and
instructions, please refer to our eCTD Basics and Getting Started Web site located
at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequire
ments/ElectronicSubmissions/ucm330116.htm
2.3 Transitioning to eCTD Format and Resubmission of non-eCTD Documents
When transitioning to eCTD format, you are not required to resubmit documents already
submitted in paper or other electronic format. Provide only new or changed information
and begin with sequence number 0001. For example, if your original application was
submitted in paper and now a supplement will be submitted to the application in eCTD
format, you should not resubmit electronic copies of documents and eCTD backbone
files for the previously submitted paper files. For INDs, there is no requirement to match
up the sequence number with the serial number.
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In most cases, the submission of a baseline or other previously submitted content will
require that the previous content be reorganized to meet the eCTD format requirements.
You should not resubmit the previous content as-is, unless the content was in the CTD
format but you did not use the eCTD backbone when content was originally submitted.
If the previous content will be submitted using us-regional v2.01, the submission-type
should be coded as "other". If the submission will be submitted using us-regional v3.3,
the submission-type should be coded as product correspondence. On the 356h form,
you should select Product Correspondence for the Submission type and enter
Submission of previous non-eCTD content in the eCTD format.
2.4 eCTD Leaf Titles
Leaf titles for eCTDs are displayed to the reviewer when viewing an eCTD application.
Although some eCTD tools generate leaf titles that are similar to file names, the two are
not related. All modules of the eCTD should contain descriptive eCTD leaf titles that
are short, meaningful, and indicative of each document's content. You should not
include the eCTD section number in the leaf title.
For documents of the same type (such as the cover letter, Form FDA 356h, and annual
report documents), you should provide additional information in the eCTD leaf title so
reviewers can distinguish documents submitted in different sequences. For example, the
leaf title for a cover letter should also include the date (e.g., 2015-12-31). Additionally,
if documents of the same type are being provided in different file formats, a file format
(e.g., MS Word) should be included at the end of the leaf title. This helps reviewers
to quickly identify which software applications are necessary to open the files.
4
The ICH Electronic Common Technical Document Specifications v3.2.2 can be accessed at:
http://estri.ich.org/eCTD/index.htm.
5
The ICH Electronic Common Technical Document Study Tagging File Specification v2.6.1 can be accessed
under
the Electronic Submissions Standards catalog. The catalog is located on the FDA eCTD website
(www.fda.gov/ectd) under the heading eCTD Documentation and Resources
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Please note: The use of "append" is not common. You should avoid appending multiple
documents to a single leaf and consider consolidating the information and using the
replace life cycle attribute to update the original file. However, it may be appropriate
if, for example, you are adding a single page of information to a lengthy document.
2.6 Presubmissions
Any information submitted in eCTD format utilizing us-regional DTD v2.01 or v3.3
before the original-application should be coded as "presubmission" and should start
with sequence 0001. A high submission sequence series (e.g., 9000) should not be used.
If utilizing DTD v3.3, code as submission-type original application and submission-
subtype presubmission. The original application will use the next available sequence
number depending on the number of submitted presubmissions.
2.7 Rolling Submissions
Rolling submissions are managed the same as presubmissions to the application until the
application is complete and ready for review. The cover letter and form should state
presubmission to rolling submission part 1 of XXX (depending on how many parts
before the final submission). The final submission completing the application should be
coded as original-application to start the respective review clock. The cover letter and
form of the final submission should state "original application part XXX of XXX of
rolling submission".
If utilizing us-regional DTD v3.3, the rolling submission should be coded as submission-
type original application with submission-subtype presubmission. The final
submission completing the application should be coded as submission-type original-
application with submission-subtype application.
6
This requirement is discussed in the eCTD Guidance available on CDERs guidance Web page in the
Electronic Submissions Standards catalog. The catalog is located on the FDA eCTD website
(www.fda.gov/ectd) under the heading eCTD Documentation and Resources
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Reviewers Guide
A reviewers guide 8 is beneficial when accompanying an original NDA, BLA, or
combination product 9 application. The reviewers guide should include a high-level
overview of the submission with hyperlinks to submitted information. The reviewers
guide should not contain a copy of the eCTD backbone table of contents. Rather, an
7
Comprehensive Table of Contents Headings and Hierarchy may be found in the Electronic Submissions
Standards catalog. The catalog is located on the FDA eCTD website (www.fda.gov/ectd) under the heading
eCTD Documentation and Resources
8
This is different than a Study Data Reviewers Guide (SDRG). Additional information on the SDRG can be
found in the Study Data Technical Conformance Guide located on at:
http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm
9
See additional recommendation for combination products in section 5 of this document
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outline format describing the submission's content is preferred, including tables or lists,
and avoiding a continuous narrative description of the applications content.
The reviewers guide should be provided as a document separate from the cover letter
and placed in section 1.2 of the eCTD with a descriptive leaf title.
3.1.3 Cross Referencing Previously Submitted Information that is not in eCTD
Format
If reference to a non-eCTD submission is needed, place a cross reference document
(e.g., table showing where to find non-eCTD documents) in m1.4.4. The information in
the document should include (1) the application number, (2) the date of submission
(e.g., letter date), (3) the file name (if applicable), (4) the page number (if necessary),
and (5) the submission identification (e.g., submission number, volume number if paper,
electronic folder if applicable) of the referenced document.
3.1.4 Labeling
This section describes how to provide specific labeling documents:
Labeling History
A history that summarizes labeling changes should be provided as a single PDF file.
The history summary should include the following information:
Complete list of the labeling changes being proposed in the current submission
and the explanation for the changes
Date of the last approved labeling
History of all changes since the last approved labeling. With each change, note
the submission that originally described the change and the explanation for the
change.
List of supplements pending approval that may affect the review of the labeling
in the current submission
Content of Labeling
The FDA guidance for industry Providing Regulatory Submissions in Electronic Format
Content of Labeling gives details on providing the content of labeling files.
Labeling Samples
Each labeling sample (e.g., carton labels, container labels, package inserts) should be
provided as an individual PDF file. The samples should:
Include all panels, if applicable
Be provided in their actual size, and
Reflect the actual color proposed for use
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Advertisements and promotional labeling materials must be submitted using version 3.3
of the us-regional.xml backbone file and submitted according to the guidance for industry
Providing Regulatory Submissions in Electronic and Non-Electronic Format
Promotional Labeling and Advertising Materials for Human Prescription Drugs.
3.1.5.2 Advertisements and Promotional Labeling to CBER
3.1.5.2.1 Using version 2.01 of the us-regional.xml file
Advertisements and promotional labeling materials may be submitted to CBER in
eCTD format using version 2.01 of the us-regional.xml backbone file.
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While HTML (a commonly used file type for websites) is an acceptable file format type
to use for eCTD Module 1 submissions, submission of HTML files that depend on
JavaScript, PHP or server-side scripts that generate dynamic content should not be
submitted in eCTD Module 1 since these dependent files are not on the list of acceptable
file format types. An acceptable alternative for these types of HTML files is to utilize
PDF. Please refer to the PDF Specifications for details. 10
3.1.6 Marketing Annual Reports
You should include a bookmark for each study or trial described in the postmarketing
requirement/commitments files. The reporting period covered by the annual report
should be included in the eCTD leaf title (e.g. Status of Postmarketing Study
Commitments - MMDDYY-MMDDYY).
3.1.7 Information Amendments
Documents for information amendments should be included in the applicable eCTD
module using the appropriate eCTD heading to describe the documents subject matter.
Section 1.11 may be used for submission of responses to Information Requests (IR),
where the information being submitted does not fit under any heading in Module 2, 3, 4
or 5. The IR response should be submitted under the appropriate subheading 1.11.1
1.11.3 within section 1.11, for quality, nonclinical, or clinical information, respectively.
The subheading 1.11.4 for multiple module information should be used if the IR
response covers multiple subject areas.
If the IR response impacts documents submitted in Modules 2 5, the new or
replacement documents should be submitted to the appropriate location in Module 2
5 and referenced from Section 1.11.
3.1.8 Letters of Authorization
Letters of Authorization (LOAs) should be submitted in Section 1.4.1 of the DMF. The
copy of the LOA that is sent by the DMF holder to the Authorized Party (company or
individual authorized to incorporate the DMF by reference) should be placed in Section
1.4.2 (Statement of Right of Reference) within the Authorized Partys application.
For additional information on LOAs and other references submitted to the eCTD
(generally for master files), refer to the Drug Master File Web
page: http://www.fda.gov/dmf
10
See Special Considerations for Promotional, Labeling, and Advertising Material in the Portable
Document Format (PDF) Specifications located in the eCTD Submission Standards catalog at:
www.fda.gov/ectd
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Typically, a single document should be provided for each study report included in this
module. However, if you are providing the study reports as multiple documents, the
subject matter of each document should be confined to a single item from the list
provided in the FDA technical specification Comprehensive Table of Contents
Headings and Hierarchy.
11
This requirement is discussed in the eCTD Guidance. Guidances are periodically updated. To make sure
you have the most recent version of a guidance, see the FDA webpage:
http://www.fda.gov/RegulatoryInformation/Guidances/default.htm. CDERs electronic submissions
guidances are located at:
http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.
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Typically, study reports should be provided according to the FDA guidance for
industry ICH E3 Structure and Content of Clinical Study Reports. The individual
documents that should be included in a study report are listed in the FDA technical
specification Comprehensive Table of Contents Headings and Hierarchy.
In cases when a legacy report has already been prepared as a single electronic
document, you should provide the entire study report as a single document, not
including the case report forms (CRFs) and individual data listings. The file tag
legacy-clinical-study-report should be used for the study report.
Human Factors Study reports should be in Module 5.3.5.4 Other Study Reports and
Related Information.
3.5.3 Case Report Forms (CRFs)
An individual subjects complete CRF should be provided as a single PDF file. If a
paper CRF was used in the clinical trial, the electronic CRF should be a scanned image
of the paper CRF including all original entries with all modifications, addenda,
corrections, comments, annotations, and any extemporaneous additions. If electronic
data capture was used in the clinical trial, a PDF-generated form or other PDF
representation of the information (e.g., subject profile) should be submitted. Each CRF
should be included with its corresponding clinical study report and should be
referenced by the reports STF, individually tagged as case-report-forms. FDA does
not use the eCTD heading 5.3.7 for CRFs, therefore do not place files under this
heading.
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Available via Electronic Submissions Standards catalog. The catalog is located on the FDA eCTD website
(www.fda.gov/ectd) under the heading eCTD Documentation and Resources
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The subjects unique identifier should be used as the title of the document and the file
name. These names are used to assist reviewers in finding the CRF for an individual
subject. Each CRF must have bookmarks as part of the comprehensive table of
contents required under 21 CFR 314.50(b). Each CRF domain and study visit should
be bookmarked to assist reviewers in their review of CRFs. For addenda and
corrections, avoid confusion by making a hypertext link from the amended item to the
corrected page or addendum. Bookmarks for these items should be displayed at the
bottom of the hierarchy.
3.5.4 Periodic Safety Reports
Periodic safety reports 13 consist of two parts: a descriptive portion and the individual
case safety reports (ICSRs). Only the descriptive portion of the periodic report may be
submitted to the eCTD.
The descriptive portion of the report may be sent as either the periodic adverse (drug)
experience report (PADER) or the ICH-E2C periodic safety update report (PSUR)
(allowed with approved waiver). Either format may be submitted to the eCTD in
section 5.3.6 as an individual PDF file without an STF. Include the reporting period in
the documents leaf title.
13
Periodic adverse drug experience reports or periodic adverse experience reports, as described in 21 CFR
314.80 and 600.80, respectively.
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3.5.7 Datasets
The FDA technical specifications document Study Data Technical Conformance Guide
provides details on the submission of datasets and related files (e.g., data definition file,
program files). 14 Datasets should be provided only in modules 3 5 of the eCTD.
This issue is also caused when multiple 3.2.P sections were submitted for multiple
strengths of the same drug product.
In general, when a single application for multiple strengths can be submitted,
information for each of the product presentations and manufacturing schemes should
be combined and presented together in one Drug Product section, with information for
each of the product presentations and manufacturing schemes provided in the
Appendices and Regional Information sections, as warranted. See FDA guidance for
industry, M4: The CTD Quality, Questions and Answers/Location Issues for more
information.
4.2 Issue: Clinical Study Report Submitted in Incorrect Section
To resolve:
Use the eCTD delete operator to delete all the leaf IDs that were referenced in the STF
under the wrong heading element. This action deletes the STF itself from our review
tool.
Create a new STF referencing all the same files, but use new leaf IDs.
Submit the updated STF in a new submission sequence.
Resubmission of files should not be necessary. Create the new leafs with file
references to the documents submitted in the original sequence.
14
Available at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.
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Contains Nonbinding Recommendations
To resolve:
Use the eCTD delete operator to delete all the leaf IDs that were not
referenced by an STF.
Create a new STF referencing all the same files, but use new leaf IDs.
Submit the STF in a new submission sequence.
Resubmission of files should not be necessary. Create the new leafs with file
references to the documents submitted in the original sequence.
4.4 Issue: Multiple Similar STF Structures Displaying in Module 4 or 5
This issue is caused by an updated STF being submitted with incorrect metadata (study-
id and study title not an exact match).
To resolve:
Use the eCTD delete operator to delete all the leaf IDs that were referenced in
the STF with incorrect study-id or study title metadata. This action deletes the
STF itself from our review tool.
Create a new STF referencing all the same files, but use new leaf IDs. Ensure
that the study-id and study title are an exact match to the original STF.
Submit the updated STF in a new submission sequence.
Resubmission of files should not be necessary. Create the new leafs with file
references to the documents submitted in the original sequence.
5. Combination Products
Combination Products 15
Generally, drug or biological product information for combination drug and device
product information and related engineering and manufacturing information should be
located in the same eCTD sections that would provide similar information for the drug
or biological product alone. This particularly applies to device constituent parts that
also serve as the drug container closure system. For example, the M3 quality module
should contain information on such devices constituents in section 3.2.P.7. Supportive
files for container closure device constituents should be located in section 3.2.R. For
other types of device constituent parts that do not have a logical location within 3.2.P,
the information should be placed in 3.2.R. For example, quality data for a free standing
laser would be in 3.2.R. Quality information on the combination product as a whole
(not the separate constituent parts) should be located in 3.2.P with appropriate
hyperlinks to 3.2.R. The following recommendations should be followed by sponsors
and applicants for combination products: 16
15
As set forth in 21 CFR part 3, a combination product is a product composed of any combination of a
drug, device, or biological product.
16
FDA recognizes the breadth of combination product designs. The information in this guide is to
promote consistency and facilitate timely review. The agency recommends that applicants, who wish to
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Files that are not currently listed as numerical items in ICH and FDA
specifications and guidance documents (e.g., Comprehensive Table of
Contents Headings and Hierarchy 18). For example, the reviewers guide
should provide reference links to each file in section 3.2.R.
Sections which are repeated through the use of different XML attributes
(e.g. <m3-2-p-drug-product product-name = Albuterol>; <m3-2-p-
drug-product product-name = Dry Powder Inhaler>)
provide data in a different location, should contact the review division for discussion. Applicants that
wish to continue to use a location based on legacy submissions for the same application may continue to
use that location.
17
If referencing previously submitted information not in the eCTD format, see section 3.1.3 of this guide-
Cross Referencing Previously Submitted Information that is not in eCTD Format
18
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/E
lectronicSubmissions/UCM163175.pdf
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4. Module 3
a. Section 3.2.P.3 Manufacture
Combination product manufacturing applies to the entire combination product
(e.g., drug device combination) in accordance with 21 CFR Part 4. 19 In Section
3.2.P.3 include applicable device information pertaining to manufacturing or
assembly of the finished combination product as a whole. As applicable, this
section may hyperlink to unique device constituent manufacturing information in
3.2.R.
i. Section 3.2.P.3.1 Manufacturer(s)
Management Controls
Design Control, General
Purchasing Controls
Corrective Action
19
21 CFR Part 4 Current Good Manufacturing Practice Requirements for Combination Products is
accessible at https://www.federalregister.gov/articles/2013/01/22/2013-01068/current-good-
manufacturing-practice-requirements-for-combination-products
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Note: Section 3.2 R does not provide for subordinate sections. Every file is listed
under a common heading. Leaf titles should be clear, concise and indicative of
the document's content. Please refer to section 2.4 of this guide for additional
information on leaf titles. In this section, for device related files, each leaf title
should be prefixed with DEVICE:
20
Guidance to Industry: Container Closure Systems for Packaging Human Drugs and Biologics;
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070551
.pdf
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5. Module 5
Human Factors Validation Study results for the combination product should be
located in eCTD section 5.3.5.4 Other Study Reports with links from
appropriate Module 3 files. Additionally, you may cross reference from Module
5 to Module 3 as applicable.
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References
The following are technical specifications documents incorporated by reference into the
guidance for industry Providing Regulatory Submissions in Electronic Format Certain
Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
Specifications. These documents are located on the FDA eCTD Web page
at: http://www.fda.gov/ectd under eCTD Documentation and Resources.
2. ICH M2 technical specification, The eCTD Backbone File Specification for Study
Tagging Files
5. ICH M2 technical specification, eCTD IWG Question and Answer and Specification
Change Request Document
6. FDA technical specification, FDA eCTD Table of Contents Headings and Hierarchy
7. FDA technical specification, Specifications for File Format Types Using eCTD
Specifications
8. FDA technical specification, FDA Portable Document Format (PDF) Specifications
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Related References
1. FDA guidance for industry, Providing Regulatory Submissions in Electronic Format
Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act
(accessible
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
default.htm under Electronic Submissions)
3. FDA guidance for industry, Formal Meetings Between the FDA and Sponsors or
Applicants (accessible
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
default.htm under Procedural)
5. FDA guidance for industry, M4: The CTD Quality, Questions and
Answers/Location Issues (accessible
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances
/default.htm under International Conference on Harmonisation - Joint Safety/Efficacy
(Multidisciplinary))
21