electronic-only filing format - IPQ

Notice
September 30, 2011
Our file number: 11-117819-54
Update: Increased Scope of Submissions being accepted in Electronic Common
Technical Document (eCTD) electronic-only filing format
Health Canada is pleased to announce an increase in the types of submissions being accepted in
the electronic-only filing format for a subset of eCTD submissions.
The measures outlined in this Notice are effective immediately since they do not impose an
obligation but rather provide more options for submission sponsors. Sponsors are
encouraged to compile submissions using the most recent Guidance Documents and Notices.
This Notice is meant to be read in conjunction with the Guidance for Industry: Preparation of
Drug Submissions in Electronic Common Technical Document (eCTD) Format. The guidance
will be changed to reflect this Notice at a future date.
It is Health Canada’s intention to continue to broaden the eCTD electronic-only scope and
future plans include those submissions currently filed in the eCTD hybrid filing format.
Electronic Common Technical Document (eCTD) Submission Filing Format
Health Canada has taken a structured approach to the adoption of eCTD format for drug
submissions. This approach consists of three stages and allows sponsors and Health Canada to
gradually gain experience with the preparation, processing and review of submissions in eCTD
format. As outlined below, the three stages correspond to the three filing formats of Submissions
in eCTD format:
1. Co-Submission Filing Format
No longer accepted by Health Canada (January 2010)
2. Hybrid Filing Format
A hybrid submission is a full submission in eCTD filing format that is accompanied by
Modules 1 and 2 in paper based CTD format. All the submission types eligible for filing
in eCTD may be submitted in the hybrid filing format.
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3. Electronic-only Filing Format
Health Canada is now accepting the submission types listed below in eCTD
electronic-only filing format, with only the cover letter being provided in the paper
format. The paper cover letter will no longer be needed once Health Canada has
secure electronic transmission of data in place.
Scope of Submissions in Electronic Common Technical Document (eCTD) Electronic-
Only Filing Format
The submissions types currently accepted in eCTD electronic-only filing format are listed below:
Drug Notification Forms (DNF) (If related to a previously filed submission for a drug
product in eCTD format.);
Periodic Safety Update Reports (PSUR) submitted to the Marketed Health Products
Directorate (MHPD);
Risk Management Plans (RMP) submitted to the Marketed Health Products
Directorate (MHPD);
Yearly Biologic Product Reports (YBPR);
Forms summarizing the Post Notice of Compliance (NOC): Notices of Change (Level
III) (If related to a previously filed submission for a drug product in eCTD format.);
Notifiable Changes (NC); and
Responses to Requests for Clarification (If related to a submission filed in eCTD
format).
New Submission Types Accepted in Electronic Common Technical Document (eCTD)
electronic-only Filing format are listed below:
Request for Priority Review Status: New Drug Submissions (PRNDS) and
Supplement to a New Drug Submission (PRSNDS);
Pre-Submission Meeting Information;
Drug Identification Number Application (DINA);
Drug Identification Number Application - Biologic (DINB).
The following submission types are eligible for filing in eCTD format however are not
currently accepted in eCTD electronic-only filing format, and therefore should be
submitted in hybrid filing format:
New Drug Submission (NDS);
Abbreviated New Drug Submission (ANDS);
Supplement to a New Drug Submission (SNDS);
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Supplement to an Abbreviated New Drug Submission (SANDS);
Periodic Safety Update Reports (PSURs) requested during the pre-market review
process by Therapeutic Products Directorate (TPD) and Biologics and Genetic
Therapies Directorate (BGTD).
Other Pharmacovigilance data requested by MHPD;
o Risk Communication documents [for example (e.g.), Health Care Professional
Letters, mailing lists]
• The eCTD copy should be sent to the Submission and Information
Policy Division (SIPD), with an electronic copy being submitted directly
to MHPD via email. The eCTD copy should be sent the same day as the
electronic copy is emailed.
o Post Marketing Surveillance [e.g., Safety or Summary Report, Council for
International Organizations of Medical Sciences (CIOMS), Line Listings,
Registry Reports or Clinical Study reports, Patient Exposure Data]
o Benefit-Risk Assessments
o Signal Work Up
o Response to MHPD Requests for Additional Information
o Notification of change in benefit-risk profile (under sections C.01.018(3) and
(4) of the Food and Drug Regulations)
Notes
i. At this time any information related to the above list of submission types not accepted in
electronic-only filing format, other than responses to Requests for Clarification, should
be submitted in hybrid filing format, for example, responses to Notice of Non-
Compliance (NON), Notice of Deficiency (NOD), and Screening Deficiency Notice
(SDN). When the above submission types are accepted in electronic-only filing format,
these responses will also be accepted in electronic-only filing format.
ii.
iii.
The cover letter and electronic media must be sent directly to SIPD in order to ensure
timely processing of these submissions.
The Letter of Attestation is not required for submissions or sequences in the eCTD
electronic-only filing format.
The following submission types are currently not accepted in the eCTD format:
Clinical Trial Applications, Amendments or Notifications (CTA, CTA-A, CTA-N);
Natural Health Products (NHP) applications;
Drug Master Files (DMF);
Site Reference Files (SRF);
Medical Devices - Licence Applications or Amendments (LAp or LAm);
Lot release documentation.
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Technical Requirements for new submission types in electronic-only filing format
Pre-Submission Meetings
The Pre-Submission Meeting packages, slide deck and minutes should be filed as leaf elements
under the m1-2-8-other-application-information subheading, at this time.
For all leaf files provided as part of the Pre-Submission Meeting Package, the operation attribute
in the leaf element should be “new”, with the possible exception of the Life Cycle Management
(LCM) table.
When a document is revised in relation to the pre-submission meeting, the operation attribute
should be “replace”.
When submitting the subsequent NDS/ANDS:
The operation attribute in the leaf element should be “new” for all leaf files provided,
with the exception of the Life Cycle Management (LCM) table.
The NDS/ANDS should be a stand alone submission. Any information provided in
relation to pre-submission meeting, if needed in the NDS/ANDS, should be resubmitted,
with the exception of meeting minutes, which may be hyperlinked.
When submitting the subsequent SNDS/SANDS:
The operation attribute ‘replace’ should be used as needed in relation to the previous
sequences (with the exception of any sequences related to pre-submission meetings).
If this is the first submission in eCTD format, the operation attribute in the leaf element
should be “new” for all leaf files provided, with the exception of the Life Cycle
Management (LCM) table.
The SNDS/SANDS should be a stand alone submission. Any information provided in
relation to pre-submission meeting, if needed in the SNDS/SANDS, should be
resubmitted, with the exception of meeting minutes, which may be hyperlinked.
Sponsors may be required to provide printed copies of the Pre-Submission Meeting Package,
upon request, as per Appendix E of the Preparation of Drug Submissions and Applications in the
Electronic Common Technical Document (eCTD).
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Priority Review Requests
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The Clinical Assessment Package (CAP) filed to support a Priority Review Request should be
filed as leaf elements under the m1-2-8-other-application-information subheading, at this time.
When the related submission is filed, the priority review acceptance letter should also be filed
under the m1-2-8-other-application-information subheading.
Application for a DINA or DINB
The information provided in support of a DINA or a DINB application should be in the CTD
format as outlined in the 2003 Draft Guidance to Industry: Preparation of New Drug
Submissions in the CTD Format. Sponsors filing a DINA/DINB application in eCTD format for
the first time are strongly recommended to request a technical pre-submission consultation with
Health Canada.
Response to a Request for Clarification (Clarifax) Process
The response to a Request for Clarification in eCTD format should be sent directly to SIPD.
Though not mandatory, it is suggested that a summary of the response in Question and Answer
format be faxed directly to the requestor. To ensure compliance with the due date, the electronic
response in eCTD format should be sent the same day as the summary is faxed. Responses to a
Request for Clarification should otherwise conform to procedures described in Health Canada's
Guidance for Industry: Management of Drug Submissions, Section 5.2.6, "Responses to
Clarification Requests".
Cover Letter for Submissions in Electronic Common Technical Document (eCTD) format
Health Canada strongly recommends that all drug submissions and subsequent additional
information in eCTD format be accompanied by an administrative cover letter in both paper and
portable document format (PDF). In addition to the content recommended by ICH, Health
Canada also requires the following:
A. All cover letters should clearly state what is being submitted, including reference to the
request letter (if applicable) and a brief description of the package.
Submission or application type
Control number
Brand name
Manufacturer / applicant's name
Central Registry (CR) file number
Any cross-referenced submission or application should be clearly stated
o Date the submission or application was approved
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Contact information for the eCTD publisher, including the email address where the
Validation Report should be sent, as needed.
eCTD identifier
Sequence number
If a Periodic Safety Update Report (PSUR) is to be submitted, one of the following types
should be indicated in the cover letter:
o Requested AD HOC PSUR - submitted as a one-time submission request
o Voluntary PSUR - unsolicited submission
o Requested Periodic PSUR - requested by Health Canada, e.g., Risk Management
Plan (RMP) follow-up or post-authorization commitment;
o PSUR-C (confirmatory) - submitted to support the fulfillment of a Notice of
Compliance with Conditions (NOC/c)
B. A table should be inserted at the end of the cover letter for submissions that contains the HC-
SC3011 form information as structured below:
Type of Submission
Number of Volumes/Disks
Drug Product
Brand Name
Common Name
Drug Identification Number Owner
-Company Name
-Legal Address
Proposed Indication
Box 5 of HC-SC3011 form
Box 6 of HC-SC3011 form
Box 64 of HC-SC3011 form
Box 8 of HC-SC3011 form
Box 9 of HC-SC3011 form
Part A
Box 11 of HC-SC3011 form
Boxes 12-16 of HC-SC3011 form
Box 67 of HC-SC3011 form
Dosage Form
Box 60 of HC-SC3011 form
Route of Administration
Box 63 of HC-SC3011 form
Medicinal (active) Ingredients
Box 56 of HC-SC3011 form
Ingredient
Name
Strength Unit Per Calculated as
Base (Yes/No)
C. The PDF cover letters include, as Appendix 1, the Life Cycle Management Table, discussed
in Section 4.3, "Life Cycle Management”. This Appendix should be submitted as a separate
file.
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D. For submissions in eCTD electronic-only filing format, please indicate in bold capital letters
‘eCTD ELECTRONIC-ONLY FILING FORMAT’ in the subject line of the cover letter.
Packaging of Submissions in Electronic Common Technical Document (eCTD) format
The following are requirements for the packaging and labeling of the eCTD submissions in the
Hybrid and the Electronic-Only Filing Formats.
Hybrid Filing Format
o A shipping box marked ‘eCTD’ containing the paper copy of Modules 1 and 2, as
applicable, and the compact dics/digital versatile discs (CD/DVD).
Electronic-Only Filing Format
o An envelope marked ‘eCTD’ containing the cover letter and the CD/DVD(s).
If you have any questions regarding the content of this notice, please contact:
Submission and Information Policy Division (SIPD)
Therapeutic Products Directorate
Health Canada
Finance Building 2,
Address Locator 0201A1
101 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Email: ereview@hc-sc.gc.ca