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