Question and Answer Document

Regulatory Activities in eCTD Format

  1. Must a sponsor provide an electronic regulatory activity in eCTD format? (Revised May 2017)
  2. (Question and Answer Removed)
  3. (Question and Answer Removed)
  4. What regulatory activity types will Health Canada accept in eCTD format, as of May 2015?
  5. Once a drug sponsor files a regulatory activity in eCTD format for a particular dossier do subsequent related regulatory activities need to be in eCTD format?
  6. What security procedures is Health Canada putting in place for the submitted CDs and DVDs?
  7. What maximum and minimum scan resolution is acceptable for scanned images included in regulatory activities in eCTD format?
  8. Are Study Tagging Files (STFs) accepted by Health Canada? If so, how should they be built?
  9. How does Health Canada handle lifecycle management?
  10. What constitutes the legal record in terms of filed regulatory activities?
  11. How to provide regulatory transactions in eCTD format (Revised May 2017)
  12. What is the change request process for Health Canada's eCTD guidance document?
  13. When should hyperlinks be used in a regulatory activity in eCTD format?
  14. What kind of external hyperlinks does Health Canada accept (and not accept) in the eCTD format?
  15. How should one obtain the unique Dossier Identifier for the first regulatory transaction in eCTD format?
  16. Will sponsors have access to Health Canada's eCTD viewing tool?
  17. Where can drug sponsors place bioequivalence (BE) data sets in regulatory activities in the eCTD format?
  18. Where does one send sample regulatory activities in the eCTD format?
  19. Will Health Canada provide a style sheet for Module 1?
  20. What version of PDF files should be provided for regulatory activities in eCTD format?
  21. Will the validation report be sent to the sponsor once the regulatory transaction in eCTD format has been validated by Health Canada?
  22. How should the Yearly Biologic Product Reports (YBPR) be filed in eCTD format?
  23. What are the folder and structure requirements when including the Applicant's Part of the Drug Master File (DMF) in a regulatory activity in eCTD format?
  24. What regulatory transactions will Health Canada accept in eCTD format?
  25. How should the "written correspondence related to the Patented Medicines (Notice of Compliance) Regulations", "consent letter" , "Form IV" and the "Form V" be provided?

 

1. Must a sponsor provide an electronic regulatory activity in eCTD format? (Revised May 2017)

As of January 1st, 2018 mandatory filing of specified regulatory activities in eCTD format will be in effect. Refer to the Notice- Mandatory use of the Electronic Common Technical Document (eCTD) format published on the Health Canada website for further details.

In addition to the Notice:

  • Administrative Regulatory Activities
    • Administrative Licencing Agreements are strongly recommended, however, not mandatory in eCTD format. 
    • All other Administrative Regulatory Activities are mandatory in eCTD format, if the existing dossier is also in eCTD format.
  • Non-Prescription Human Drugs regulated under:
    • Division 1 of the Food and Drug Regulations (i.e. DINA, DINB, DIND, DINF and PDC) are recommended, however, not mandatory in eCTD format.   If these regulatory activities are not submitted in eCTD format, they must be provided in "non-eCTD electronic - only" format.
    • Division 8 of the Food and Drug Regulations (i.e. NDS, SNDS, ANDS and SANDS including their subsequent transactions) will be mandatory in eCTD format as of January 2018.  However, when sponsors are filing regulatory transactions (ie. NC, RMP, and PSUR) for existing dossier they will only be mandatory in eCTD format if the initial regulatory activity was also filed in eCTD format.
    • Exemptions from the mandatory eCTD format requirement may be considered, on a case by case basis.  Please refer to the Notice - Mandatory use of the eCTD format for details.

2. (Question and Answer Removed)

3. (Question and Answer Removed)

4. What regulatory activity types will Health Canada accept in eCTD format, as of May 2015?

As of May 2015, Health Canada has clarified the scope of regulatory activity types and regulatory transactions accepted in eCTD format.  See section 1.3 of the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format for a complete list.

5. Once a drug sponsor files a regulatory activity in eCTD format for a particular dossier do subsequent related regulatory activities need to be in eCTD format?

Yes, as per section 5 of the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format once a sponsor files a regulatory activity  in eCTD format, all additional information and subsequent regulatory activities for the same dossier must be filed in eCTD format.

6. What security procedures is Health Canada putting in place for the submitted CDs and DVDs?

Health Canada will be uploading the data found on the CDs and DVDs to a secure server, on which all processing and review will be performed. The CDs and DVDs will be stored in a secure environment for three months before they are shredded using a shredder that meets the standard for confidential business information (CBI).

7. What maximum and minimum scan resolution is acceptable for scanned images included in regulatory activities in eCTD format?

Health Canada will adhere to the specifications outlined in the Electronic Common Technical Document Specification (Version 3.2.2), developed by the International Council for Harmonisation (ICH) M2 Expert Working Group (EWG).

8. Are Study Tagging Files (STFs) accepted by Health Canada? If so, how should they be built?

Yes, files organized with Study Tagging Files (STFs) are accepted.  If STFs are used, they should be built according to the ICH eCTD STF Specification V 2.6.1.

Refer to section 2.4.2 of the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format.

9. How does Health Canada handle lifecycle management?

The answer to this question can be found in the eCTD Guidance Document.

Refer to section 3.3 of the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format.

10. What constitutes the legal record in terms of filed regulatory activities?

The electronic regulatory activity in eCTD format is the legal document; therefore emails provided directly to reviewers have no legal value and are considered a convenience copy. The information provided via email to reviewers should always be followed by a regulatory transaction in eCTD format.

11. How to provide regulatory transactions in eCTD format (Revised May 2017)

Effective January 1st, 2017, Health Canada applied the mandatory transmission requirement for all regulatory transactions that are less than 10GB in size and prepared in the eCTD format, via the Common Electronic Submissions Gateway (CESG).  Please refer to the Frequently Asked Questions - Common Electronic Submission Gateway (CESG FAQ) and the Notice - Mandatory Requirements Common Electronic Submission Gateway (CESG) documents for details on the utilization of the CESG.

Sponsors providing transaction larger than 10 GB in size should continue to use media for transmission. For detailed information on how to file using media, refer to Section 3.2 (ii) of the Guidance Document - Preparation of Regulatory Activities in eCTD Format.

12. What is the change request process for Health Canada's eCTD guidance document?

Interested parties are welcome to forward comments at any time on Health Canada's Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format. It is expected that this guidance document will be further modified at intervals based on comments received, experience gained, and further ICH developments. Comments may be forwarded to ereview@hc-sc.gc.ca. Health Canada will review all requests and comments for inclusion in consultation with stakeholders.

13. When should hyperlinks be used in a regulatory activity in eCTD format?

Hyperlinks should be provided throughout a regulatory activity to aid efficient navigation to annotations, related sections, publications, appendices, tables, and figures that are not located on the same page. Overuse of hyperlinks lengthens the processing of the regulatory transaction and may create confusion for the reviewers; therefore their use should be well thought out.

See section 3.5 of the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format for more details.

14. What kind of external hyperlinks does Health Canada accept (and not accept) in the eCTD format?

External hyperlinks currently result in a validation error that would normally cause a regulatory transaction to fail validation. However, including some links to a web page "www.*****" (such as sponsors own websites) or e-mail addresses "*****@****" are acceptable in some labelling documents and literature references. Any external links to information pertinent to the review process will result in a validation failure. Information pertinent to the review process should be included within the regulatory activity as a PDF or another appropriate file type.

15. How should one obtain the unique Dossier Identifier for the first regulatory transaction in eCTD format?

Prior to filing the first regulatory transaction for a dossier in eCTD format, the sponsor should provide a written request to OSIP via email (ereview@hc-sc.gc.ca) to obtain a Dossier Identifier.

Refer to section 2.3.1 of the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format.

Note: that the requirement to obtain a Dossier Identifier from Health Canada does not apply to eCTD samples

16. Will sponsors have access to Health Canada's eCTD viewing tool?

Health Canada will not provide access to their eCTD viewing tool since Health Canada has selected a commercial, off-the-shelf solution.

17. Where can drug sponsors place bioequivalence (BE) data sets in regulatory activities in the eCTD format?

The "BE data sets should be filed as leaf elements under the m1-6-1-comparative-bioavailability-information heading.

The "BE data sets" must be provided in ASCII format. For more information see Health Canada's Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format, Appendix B: "Computer Format for the Submission of Data for Comparative Bioavailability Studies".

18. Where does one send sample regulatory activities in the eCTD format?

It is strongly recommended that the sample in eCTD format be provided via the CESG. If not using CESG, the package should be sent to OSIP and include a paper cover letter and the disc containing the sample.

A sample regulatory activity in eCTD format should be submitted to OSIP according to the requirements indicated in section 4.2 of the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format.

19. Will Health Canada provide a style sheet for Module 1?

No.

20. What version of PDF files should be provided for regulatory activities in eCTD format?

As per the ICH Electronic Common Technical Document Specification (Version 3.2.2), Health Canada requires the provision of components of the regulatory activity in eCTD format as PDF files (versions 1.4 to 1.7, PDF/A-1 and PDF/A-2).

See section 3.1 of the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format for more information.

21. Will the validation report be sent to the sponsor once the regulatory transaction in eCTD format has been validated by Health Canada?

Every sequence received by Health Canada is validated, a written eCTD Validation Report describing the deficiencies will be issued to the sponsor for regulatory transactions that fail validation or validate with warnings. However, the report will be emailed to the sponsor only if there is an email address included in the cover letter indicating to whom the validation report should be sent. Multiple email addresses are acceptable.

For regulatory transactions received on approved media via mail, a Validation Report will be issued within 7 calendar days. This timeline will decrease to 24 business hours for regulatory transactions received via CESG.

22. How should the Yearly Biologic Product Reports (YBPR) be filed in eCTD format?

When the Yearly Biologic Product Report (YBPR) is provided as a single document, it should be filed as a leaf element under the m3-2-r-4-yearly-biologic-product-reports heading.

When the YBPR is provided as multiple documents (YBPR, Analysis of Adverse Drug Reaction, and Recalls) they should be filed as leaf elements under the m3-2-r-4-yearly-biologic-product-reports heading and all other documents listed in section 5.1 of the Guidance for Sponsors: Lot Release Program for Schedule D (Biologic) Drug should be filed as leaf elements under the appropriate headings in module 3.

In both of the cases indicated above, the CPID should be provided as a separate document, filed as a leaf element under the m1-3-6-certified-product-information-document heading.

23. What are the folder and structure requirements when including the Applicant's Part of the Drug Master File (DMF) in a regulatory activity in eCTD format?

See section 2.4.2 i) of the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format for more information and illustrations.

24. What regulatory transactions will Health Canada accept in eCTD format?

The scope of regulatory transactions accepted in eCTD format, as defined in section 1.3 of the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format, has been revised to also include the following:

Transaction Sequence Description
Written correspondence related to the Patented Medicines (Notice of Compliance) Regulations Correspondence - Patented Medicines
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 Notice of allegation
Form IV, including updates, filed in accordance with the Patented Medicines (Notice of Compliance) Regulations Form IV
Form V, including updates, filed in accordance with the Patented Medicines (Notice of Compliance) Regulations Form V
Consent Letter (Patent Information) Consent Letter
Written correspondence related to data protection under section C.08.004.1 of the Food and Drug Regulations Correspondence - Data Protection
Consent Letter (Data Protection Information) Consent Letter

25. How should the "written correspondence related to the Patented Medicines (Notice of Compliance) Regulations", "consent letter" , "Form IV" and the "Form V" be provided?

When submitting multiple patent forms as new or to replace previously submitted ones:

  • The multiple forms should be submitted in one sequence
  • The forms should always be submitted using the original regulatory activity type (NDS, ANDS).

When submitting written correspondence related to the Patented Medicines (Notice of Compliance) Regulations or consent letters, the document:

  • Should be submitted in one sequence
  • Should always be submitted using the original regulatory activity type (NDS, ANDS).

Submitting patent forms or written correspondence for older activities that were submitted in paper and converted to eCTD, must be submitted in eCTD format.

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