Guidance Document: The Management of Drug Submissions and Applications

Overview

This guidance document gives sponsors and Health Canada staff operational direction and guidance when managing information submitted in accordance with the Food and Drugs Act and Regulations.

Who this guide is for

• Sponsors of pharmaceuticals, biologics, and radiopharmaceutical drugs for human use

In this guide

1. 1. Introduction
   1. 1.1 Purpose/overview
2. 2. Scope and application
3. 3. Policy objectives
4. 4. Background
5. 5. Classification of a therapeutic product
   1. 5.1 Combination products
   2. 5.2 Other regulations that influence the classification of a drug
6. 6. Specific submission/application pathways
   1. 6.1 Priority review
   2. 6.2 Notice of Compliance with conditions (NOC/c)
   3. 6.3 Extraordinary use new drug
   4. 6.4 Biosimilar biologic drug
   5. 6.5 Administrative processing
7. 7. Guidance for implementation
   1. 7.1 Pre-Submission or pre-application meetings
      1. 7.1.1 Meeting requests
      2. 7.1.2 Meeting packages
      3. 7.1.3 Post-meeting requirements
8. 8. Filing of information to Health Canada
   1. 8.1. Acceptable formats for filing submissions/applications
   2. 8.2 Filing formats and where to file for CTAs and CTA-As
   3. 8.3 Transmission of electronic data
9. 9. Submission/application processing
   1. 9.1 Processing of an initial submission/application
   2. 9.2 Cancellation or withdrawal letter during the processing period
   3. 9.3 Submissions/applications for administrative processing
10. 10. Screening of submissions/applications
    1. 10.1 Screening of a submission/application during the Screening 1 period
       1. 10.1.1 Cancellation letter during the Screening 1 period
       2. 10.1.2 Screening Acceptance Letter (SAL)
    2. 10.2 Solicited Information
       1. 10.2.1 Clarification Requests during the Screening 1 period
       2. 10.2.2 Response to a Clarification Request during the Screening 1 period
       3. 10.2.3 Screening Deficiency Notice (SDN)
          1. 10.2.3.1 Response to Screening Deficiency Notice (SDN)
          2. 10.2.3.2 Acceptance letter following the response to a Screening Deficiency
          3. 10.2.3.3 Screening Rejection Letter (SRL)
11. 11. Scientific Review of submissions/applications
    1. 11.1 Scientific Review process
       1. 11.1.1 Screening solicited and unsolicited information submitted during the Scientific Review
       2. 11.1.2 Cancellation letter during the Scientific Review
       3. 11.1.3 Pause the Clock during the Scientific Review
12. 12. Solicited information during the Scientific Review
    1. 12.1 Solicited information
       1. 12.1.1 Clarification Request during the Scientific Review
       2. 12.1.2 Response to a Clarification Request during the Scientific Review
       3. 12.1.3 Notice of Deficiency (NOD) - NDS, SNDS, ANDS, SANDS or an Application for a DIN (DINA, DINB, DIND)
          1. 12.1.3.1 Response to Notice of Deficiency (NOD) - NDS, SNDS, ANDS, SANDS or an Application for a DIN (DINA, DINB, DIND)
          2. 12.1.3.2 Acceptance of a response to a Notice of Deficiency (NOD)
          3. 12.1.3.3 Notice of Deficiency Withdrawal letter (NOD-W)
13. 13. Completion of the Scientific Review of a submission/application
    1. 13.1 Processing of the submission/application following completion of the review
    2. 13.2 Notice of Compliance (NOC) - NDS, SNDS, ANDS, SANDS, EUNDS, EUSNDS, EUANDS, AEUSNDS, NDS-D, SNDS-D, SNDS-c, SANDS-c
    3. 13.3 No Objection Letter (NOL) - Application for a DIN (DINA, DINB, DIND), NC, PDC-prescription, PDC-non-prescription, PDC-disinfectant, PDC-B, CTA, CTA-A
    4. 13.4 Not Satisfactory Notice (NSN) - NC, PDC-prescription, PDC-non-prescription, PDC-disinfectant, PDC-B, CTA, CTA-A
    5. 13.5 Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN)
    6. 13.6 Notice of Non-Compliance (NON) - NDS, SNDS, ANDS, SANDS, or an Application for a DIN (DINA, DINB, DIND)
       1. 13.6.1 Response to a Notice of Non-Compliance (NON)
       2. 13.6.2 Acceptance of a response to a Notice of Non-Compliance (NON)
       3. 13.6.3 Notice of Non-Compliance Withdrawal letter (NON-W)
14. 14. Unsolicited information
    1. 14.1 Safety information
       1. 14.1.1 Information that may be submitted at any time during the submission process
       2. 14.1.2 Information that will not be accepted once the submission has been accepted for review
    2. 14.2 Foreign regulatory information
       1. 14.2.1 Assessment reports
       2. 14.2.2 Correspondence
    3. 14.3 Reports from an expert or from expert advisory committees
    4. 14.4 Changes in the manufacturer's/sponsor's name and/or product name during the processing, screening or review of a submission/application
    5. 14.5 Efficacy data
    6. 14.6 Stability data
15. 15. Refiled submissions or applications
    1. 15.1 Refiling a submission/application following a screening rejection letter
    2. 15.2 Refiling of a submission/application following a cancellation by the sponsor
    3. 15.3 Refiling of a CTA/CTA-A following the withdrawal by the sponsor
    4. 15.4 Refiling a submission/application following a Notice of Deficiency (NOD) withdrawal
    5. 15.5 Refiling a submission/application in 5 years or less following a Not Satisfactory Notice (NSN)
    6. 15.6 Refiling a submission/application in 5 years or less following a NON-W, a cancellation following the issuance of a NON (prior to the issuance of a NON-W)
    7. 15.7 Refiling of a submission/application more than 5 years after receipt of a NON-W, cancellation following the issuance of a NON (prior to the issuance of a NON-W) or a NSN
16. 16. Reconsideration of decisions issued for human submissions and applications
17. 17. Accessing submission information
    1. 17.1 Scientific review reports
    2. 17.2 Drug Submission Tracking System (DSTS) - industry access
    3. 17.3 Status requests
18. Appendix 1
    • Definitions
19. Appendix 2
    • Review centre/bureau/office responsibilities and contact information
20. Appendix 3
    • Performance standards for drug submission/application review
21. Appendix 4
    • Notes for the Performance standards for drug submission/application review table in Appendix 3
    • Glossary of abbreviations
    • Notes on terminology
22. Appendix 5
    • Types of administrative holds
23. Appendix 6
    • Issuance of decision documents
24. Appendix 7
    • Guidance and policy documents on drugs
    • Documents on clinical trials
    • Documents on medical devices and combination products
    • Documents on biologics
    • Documents on pharmacovigilance monitoring

View complete Guide

Download PDF (684 KB, 74 pages)

Details and history

• Published: Pre 1993/12/19
• Updated: 2022/08/02
• Consulted: N/A
• Part of topic(s): Guidance on legislation

For assistance

Contact us:

Pharmaceutical Drugs Directorate
Director General's Office
Health Products and Food Branch
Address Locator: 3106B
Ottawa ON K1A 0K9

Telephone: 613-957-0368
Fax: 613-952-7756
Teletypewriter: 1-800-465-7735 (Service Canada)

E-mail: pharma_drug_enquiries-renseignements_medicaments_pharma@hc-sc.gc.ca