Appendix 7 Specification For Submission Formats For Essays

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.

Legend

Division 1
Part C, Division 1 of the Food and Drug Regulations (e.g., DINA, DINB).
Division 5
Part C, Division 5 of the Food and Drug Regulations (e.g., CTA, CTA-A, CTA-N, CTSI).
Division 8
Part C, Division 8 of the Food and Drug Regulations (e.g., NDS, SNDS, ANDS, NC).
DSUR
Developmental Safety Update Report (DSUR).
Post-market Vigilance Data
Post-market Vigilance Data (e.g., PSUR, PBER, RMP).
Level III
Post NOC Level III Changes Forms pursuant to Guidance Document: Post-Notice of Compliance (NOC) Changes: Framework Document.
DNF
Drug Notification Forms (DNF) pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations.
Master Files
Master Files (MF).
Medical Devices
Medical Device Regulatory Activities pursuant to section 32 of the Medical Devices Regulations (e.g., Class II, III & IV licences & amendments, and Faxback amendments).
Veterinary Drugs
Veterinary Drugs pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations.

Table of Contents

1. Introduction

Health Canada is pleased to announce a revision to the Guidance Document: Preparation of Drug Regulatory Activities in the “Non-eCTD Electronic-Only” Format, published in February 2016,to include Medical Device and Veterinary Drug regulatory activities in “non-eCTD electronic-only” format.

This document defines the filing requirements and provides guidance on the structure, content and format of regulatory activities filed in “non-eCTD electronic-only” format.

Future refinements and subsequent iterations of this guidance document will continue to be necessary as a result of the transition from paper format to electronic format.

Health Canada would like to provide an advanced notice that we are considering January 1st, 2018 for mandatory filing of all NDS, SNDS, SANDS and ANDS regulatory activities (for human drugs) in eCTD format. Once a sponsor files a regulatory activity in eCTD format, all additional information and subsequent regulatory activities (such as NC, PSUR, RMP, etc.) must also be filed in eCTD format. The mandatory eCTD requirement is established to keep aligned with other regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Questions or comments regarding this advanced notice can be sent to ereview@hc-sc.gc.ca.

1.1 Policy Objectives

To integrate the “non-eCTD electronic-only” format within the Canadian drug registration framework by describing the requirements for the preparation of:

  • An application for Drug Identification Number (DIN) pursuant to Part C, Division 1 of the Food and Drug Regulations
  • A Clinical Trial involving human subjects pursuant to Part C, Division 5 of the Food and Drug Regulations
  • A human drug regulatory activity pursuant to Part C, Division 8 of the Food and Drug Regulations
  • Developmental Safety Update Reports (DSUR)
  • Post-market Vigilance Data
  • Post-Notice of Compliance (NOC) Changes: Level III forms pursuant to Guidance Document: Post-Notice of Compliance (NOC) Changes: Framework Document
  • Drug Notification Forms (DNF) pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations
  • Administrative Regulatory Activities pursuant to Part C, Division 8 of the Food and Drug Regulations
  • Master Files (MF)
  • Medical Device regulatory activities pursuant to sections 32 and 82 of the Medical Devices Regulations
  • Veterinary drug regulatory activities pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations

To consolidate several notices regarding different product lines that are published in different locations into one single document for ease of access by stakeholders. Completing the consolidation of the published notices and increasing the scope of regulatory activities accepted in “non-eCTD electronic-only” format will result in several iterations of this guidance document.

1.2 Policy Statements

As part of an ongoing efficiency measure and efforts to reduce regulatory burden on industry as well as to transition to an electronic environment, Health Canada has established the following options that are available immediately for filing regulatory activities in scope of this document and their related transactions:

  1. Health Canada has been accepting regulatory activities in electronic Common Technical Document (eCTD) format since 2004. Therefore, the recommended option is to file regulatory activities/transactions in the eCTD format (where applicable). Refer to the Guidance Document: Preparation of Regulatory Activities in the electronic Common Technical Document (eCTD) Format, for further information.
  2. In the situation that a regulatory activity/transaction is not yet accepted in eCTD format by Health Canada, an interim option is to file the regulatory activity/transaction in the “non-eCTD electronic-only” format until it is accepted in either the eCTD format or in the Regulated Product Submission (RPSFootnote 1) format.
  3. If a stakeholder is not ready to file in the eCTD format, they may file regulatory activities/ transactions in the “non-eCTD electronic-only” format as an interim option until their transition to the eCTD format has been completed.

Health Canada has been accepting Class III and IV medical device applications in electronic and paper format since November 2014. Effective immediately, Health Canada is accepting all medical device applications in scope of this guidance document to be provided in “non-eCTD electronic-only” format. Until the Regulated Product Submission (RPS1) format has been implemented, “Non-eCTD electronic-only” will be the only format accepted by Health Canada for medical devices applications as of April 1st, 2017. Therefore paper will no longer be accepted as of this date.

Regulatory Activities provided in electronic-only format have been accepted by Health Canada since 2014. Effective April 1st, 2017, Health Canada will no longer accept the paper copies. Therefore, “non-eCTD electronic-only” will be the only format accepted.

Electronic documents filed using any of the above options will be uploaded onto the Health Canada viewing tool, where they will be immediately accessible to Health Canada staff involved in the review of the regulatory activities. This will contribute to effective record management and ensure authenticity, integrity, availability, traceability, and non-repudiation of the data.

1.3 Scope and Application

The following regulatory activity types are eligible for filing in “non-eCTD electronic-only” format:

  • New Drug Submission (NDS)Footnote 2
  • Extraordinary Use New Drug Submission (EU NDS)
  • Abbreviated New Drug Submission (ANDS)Footnote 2
  • Supplement to a New Drug Submission (SNDS)Footnote 2
  • Extraordinary Use Supplement to a New Drug Submission (EU SNDS)
  • Supplement to a New Drug Submission-Confirmatory (SNDS-C)
  • Supplement to an Abbreviated New Drug Submission (SANDS)Footnote 2
  • Notifiable Change (NC)Footnote 2
  • Request for Priority Review Status for NDS or SNDS
  • Yearly Biologic Product Report (YBPR)Footnote 3
  • Periodic Safety Update Report - Confirmatory (PSUR-C) or Periodic Benefit Risk Evaluation Report - Confirmatory (PBRER-C) when provided to TPD, BGTD or NNHPD
  • Pre-Submission Meeting InformationFootnote 4 (MPNDS, MPSNDS, MPDIN, or MPNC)
  • Undefined Regulatory Activity (UDRA)
    • Response to Advisement Letter to update the Product Monograph, when an NC (or other Division 8 regulatory activity) is not filed
    •  Notification of Discontinued Sale (DIN Cancellation)
  • Periodic Safety Update Report (PSUR) or Periodic Benefit Risk Evaluation Report (PBRER) when provided to the Marketed Health Products Directorate (MHPD)Footnote 5
  • Risk Management Plan (RMP), when provided to MHPDFootnote 5
  • Other Post-market Vigilance dataFootnote 6 (Undefined Data Post-market Vigilance (UDPV)) requested by MHPDFootnote 5
    • Risk communication document (e.g., Dear Health Care Professional Letter, dissemination lists, Proposed Dissemination Strategy) should be sent to the Office of Submissions and Intellectual Property (OSIP) with an electronic convenience copy being provided directly to MHPD via email
    • Post-market Surveillance (e.g., Issue-related Summary Reports, Council For International Organizations Of Medical Sciences (CIOMS), Line Listings, Registry Reports, Clinical Study Reports, or Patient Exposure Data)
    • Benefit Risk Assessment
    • Response to MHPD Requests for Additional Informationotnote 7
    • Notification of Change in benefit-risk profile (under sections C.01.018(3) and (4) of the Food and Drug Regulations)
    • Meetings regarding post marketing issues with MHPD
  • Application for Drug Identification Number (DIN)
  • New Drug Submission (NDS)Footnote 2
  • Abbreviated New Drug Submission (ANDS)Footnote 2
  • Supplement to a New Drug Submission (SNDS)Footnote 2
  • Supplement to an Abbreviated New Drug Submission (SANDS)Footnote 2
  • Notifiable Change (NC)Footnote 2
  • Request for Priority Review Status for NDS or SNDS
  • Periodic Safety Update Report (PSUR)
  • Pre-Submission Meeting InformationFootnote 4 (e.g., MPNDS, MPSNDS, MPDIN, or MPANDS)
  • Change to DIN Submission
  • Experimental Studies Certificate (ESCs) and their amendments
  • Investigational New Drug (IND)
  • Investigational New Drug (IND) amendments
  • Protocol Review
  • Veterinary Drugs Master Files (MF)

Any transaction related to the above regulatory activity types are accepted in “non-eCTD electronic-only” format. These transactions include, however are not limited to, the following:

Regulatory TransactionDiv. 1Div. 5Div. 8MFMDVDD
Response to a Clarification Request (also known as Response to Minor Information Request for Veterinary Drugs)
Responses to Notice of Non-compliance (NON) and Notice of Deficiency (NOD) n/an/an/a
Response to Notice of Compliance with Condition Qualifying Notice (NOC/c-QN) or update Notice n/an/an/an/a
Response to Screening Deficiency Notice (SDN) n/an/a
Second Language Product Monograph or Prescribing Informationn/an/an/an/a

Drug Notification Form (DNF)

n/an/an/a

Notification of Discontinued Sale (DIN Cancellation)

n/an/an/a
Notification for the interruption of sale for a period of 12 months or moreTable 1 footnote *n/an/an/an/a
Notification for recommencing sale of a drugTable 1 footnote *n/an/an/an/a
Consistency Lot Testing Activities (Sample Requests) requested during the pre-market review process by BGTDn/an/an/an/a
PSUR requested during the pre-market review process by TPD, BGTD, VDD or NNHPD n/an/an/an/a
PBRER requested during the pre-market review process by TPD, BGTD, or NNHPD n/an/an/an/an/a
RMP requested during the pre-market review process by TPD, BGTD or NNHPD n/an/an/an/an/a
DSUR requested during the pre-market review process by TPD, BGTD or NNHPD n/an/an/an/an/a
Comments to the Summary Basis of Decision/ Notice of Decision n/an/an/an/an/a
Written correspondence related to the Patented Medicines (Notice of Compliance) Regulations n/an/an/an/a
Notice of allegation and related materials (i.e. notice of allegation, proof of service, certification of filing date) under the Patented Medicines (Notice of Compliance) Regulations n/an/an/an/a
Form IV, including updates, filed in accordance with the Patented Medicines (Notice of Compliance) Regulationsn/an/an/an/a
Form V, including updates, filed in accordance with the Patented Medicines (Notice of Compliance) Regulationsn/an/an/an/a
Consent Letter (Patent Information) n/an/an/an/a
Written correspondence related to data protection under section C.08.004.1 of the Food and Drug Regulations n/an/an/an/an/a
Consent Letter (Data Protection Information) n/an/an/an/an/a
Documents related to data protection under section C.08.004.1 of the Food and Drug Regulationsn/an/an/an/an/a
Authorization for Sharing Information (Consent Letter) n/an/an/an/a
Reconsideration of Decisions and Other Related Information n/an/an/an/a
MF Updates (updates or amendments) n/an/an/an/a
MF Response to Deficiency Letter or Incomplete Letter n/an/an/an/a
CEP and Attestations n/an/an/an/a
CEP Revisions and Attestations n/an/an/an/a
MF Administrative Information n/an/an/an/a
MF Authorization to Access n/an/an/an/a
MF Statement of Commitment n/an/an/an/a
MF BSE/TSE Certificate n/an/an/an/a
Response to Additional Information Letter n/an/an/an/an/a
Response to Screening Deficiency Letter (SDL) n/an/an/an/an/a

1.4 Background

A first iteration of this document was developed to include DIN applications and published in June 2015. A second iteration of the document introduced MFs in “non-eCTD electronic-only” format and was published in September 2015. In February 2016, the third iteration widening the scope to introduce Part C, Division 5 and Division 8 (human drugs) of the Food and Drugs Regulations was published. This fourth iteration again expands the scope of regulatory activities accepted to include Medical Device applications as well as veterinary drugs by incorporating information from the following notices:

  • Notice – Guidance for Industry: Formatting of Class III and Class IV License Applications (Electronic and Paper Formats)
  • Guidance for industry - Preparation of electronic submissions for the Veterinary Drugs Directorate

This guidance should be read in conjunction with the following documents:

Stakeholders that choose to file a regulatory activity or transaction in eCTD format must comply with the scope and the specifications included in the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format.

2. Structure and Content of a Regulatory Activity

Health Canada would like to emphasize that the requirements highlighted below are not limited to initial regulatory activities as defined in section “1.3 Scope and Application”. The requirements also apply to all regulatory transactions (see Table 2 in section 1.3 “Scope and Application”). Any transactions not formatted as per this guideline, will be rejected.

2.1 Cover Letter

Regulatory activities in “non-eCTD electronic-only” format provided on media must include a cover letter, in both electronic format and paper format. A paper cover letter is required as this is the only means by which to quickly identify the content of the media. In addition, the following are exceptions to this requirement:

Health Canada requires the following information for all cover letters:

  • Clearly state what is being provided and the reason for filing, for example:
    • Type of transaction as per section “1.3 Scope and Application”,
    • Notification for the interruption of sale for a period of  12 months or more
    • Notification for recommencing sale of a drug
    • Special requests (DNF)
    • Request for Review reports
    • Request for Pre-Submission Meeting
  • Include reference to correspondence with Health Canada prior to filing
  • Include reference to a request letter (including an Advisement Letter), if applicable.
  • StakeholderFootnote 11 Name and Role (e.g. Sponsor, Manufacturer, DIN / MF Owner, or Agent).
  • Brand name, MF name or Device name
  • Control number, DSTS number, MF number or Application number (if known)
  • Dossier identifier (if known)
  • Regulatory activity type
  • Any cross-referenced regulatory activity should be clearly stated (date the regulatory activity was approved).

In addition to the above general requirements, the cover letters for:

  • Response to a request for clarification:
    • Should clearly indicate the name of the requester.
    • Should not contain any scientific information. Supporting data should be placed in the appropriate module/section/part.
    • Should not include the summary response in a Question and Answer format and the Note to Reviewer. For human drugs, these should be placed in folders 1.0.4 and 1.0.7 respectively.
  • Regulatory transactions for human drugs, that contain an HC-SC3011 form should include a table, structured as below, placed at the end of the cover letter. The information required to fill the table should be taken from the indicated box numbers of the completed HC-SC3011 form.
InformationHC-SC3011 Form Box Number
Regulatory Activity Type< Box 5 >
Brand Name< Box 8 >
Common Name< Box 9 >
Stakeholder Name< Box 11 >
Stakeholder Legal Address < Boxes 12-16 >
Dosage Form< Box 60 >
Route(s) of Administration< Box 63 >
Drug Product< Box 64 >
Proposed Indication/Use< Box 67 >
Phase of Clinical TrialTable 3 footnote *

< Box 86 >

Medicinal (Active) Ingredient(s)Ingredient NameStrengthUnitPerCalculated as Base? (Yes/No)
< Box 56 >

2.2 Folder Structure

The content of the electronic media should be organized in folders.

Table Sample folder structures for specific regulatory activity types are illustrated in the locations indicated below:

  • Division 1 - Appendix C
  • Division 5 - Appendix D
  • Division 8 - Appendix E
  • Level III Changes - Section 2.2 Folder Structure
  • Drug Master Files (MF) - Appendix F
  • Medical Devices - Appendix H
  • Veterinary Drugs - (Zip file - 66 Kb) The attached zipped folder structure (available in the HTML version of this document) can be used by adding documents in their respective folders. Empty folders must be deleted before filing to Health Canada.

Date adopted: 2016/10/25
Effective Date: 2016/10/25
Revised Date: 2016/10/31

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

DateDescription
June 15, 2015Notice: Health Canada’s requirements for filing a regulatory activity in “non-eCTD electronic-only” format. (DIN)
September 25, 2015Guidance Document: Preparation of Drug Regulatory Activities in “Non-eCTD Electronic-Only” Format. (DIN, MF)
February 29, 2016Guidance Document: Preparation of Drug Regulatory Activities in “Non-eCTD Electronic-Only” Format. (Div.1, Div.5, Div.8, DSUR, Post-market Vigilance, Level III, DNF and MF)
October 31, 2016Guidance Document: Preparation of Regulatory Activities in “Non-eCTD Electronic-Only” Format. (Medical Devices, and Veterinary Drugs)
Regulatory Activity (and subsequent transactions)PaperTable 1 footnote d will no longer be accepted as of:
Division 1Table 1 footnote a (e.g.: DINA, DINB…)Already in effect
Division 5 (e.g.: CTA, CTA-N…)
Division 8Table 1 footnote a (e.g.: NDS, ANDS…)
DSUR
Post-market Vigilance Data
Level III forms
DNF
Master Files (New MFs, MF UpdatesTable 1 footnote b, Transactions related to existing MFsTable 1 footnote c)
Medical Devices (e.g.: Class II, III, & IV  licences & amendments)April 1, 2017
Veterinary DrugsApril 1, 2017

Она присела на решетчатой площадке. - Коммандер. Стратмор даже не повернулся.

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