Click here to load reader

DRAFT Guidance Document for Industry - Preparation Guidance... · PDF fileDRAFT Guidance Document for Industry - Preparation and Submission of Summary Reports for Marketed Health

  • View
    221

  • Download
    0

Embed Size (px)

Text of DRAFT Guidance Document for Industry - Preparation Guidance... · PDF fileDRAFT Guidance...

  • DRAFT Guidance Document for Industry - Preparation and Submission of Summary Reports for Marketed Health Products Annual Summary Reports and Issue-Related Summary Reports (effective date: Month dd, yyyy)

  • Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. We assess the safety of drugs and many consumer products, help improve the safety of food, and provide information to Canadians to help them make healthy decisions. We provide health services to First Nations people and to Inuit communities. We work with the provinces to ensure our health care system serves the needs of Canadians. galement disponible en franais sous le titre : XXXXXXXXXXXXXXXXXXXXXXXX To obtain additional information, please contact: Health Canada Address Locator 0900C2 Ottawa, ON K1A 0K9 Tel.: 613-957-2991 Toll free: 1-866-225-0709 Fax: 613-941-5366 TTY: 1-800-465-7735 E-mail: [email protected] This publication can be made available in alternative formats upon request. Her Majesty the Queen in Right of Canada, as represented by the Minister of Health, 2015 Publication date: Month 2015 This publication may be reproduced for personal or internal use only without permission provided the source is fully acknowledged. Cat.: XXXXXXX ISBN: XXXXXXX Pub.: XXXXXXX

  • Guidance Document for Industry - Preparation and Submission of Summary Reports for Marketed Health Products i

    Forward 1

    2 Guidance documents are meant to provide assistance on how to comply with governing statutes and regulations. 3 Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be 4 implemented in a manner that is fair, consistent and effective. 5 6 Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in 7 approach. Alternate approaches to the principles and practices described in this document may be acceptable 8 provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the 9 relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not 10 been met. 11 12 As a corollary to the above, it is equally important to note that Health Canada reserves the right to request 13 information or material, or define conditions not specifically described in this document, in order to allow the 14 Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed 15 to ensuring that such requests are justifiable and that decisions are clearly documented. 16 17 This document should be read in conjunction with relevant sections of other applicable guidance documents. 18 19

  • Guidance Document for Industry - Preparation and Submission of Summary Reports for Marketed Health Products iii

    Table of Contents 20

    1 Introduction ........................................................................................................................................................ 1 21

    1.1 Objectives ...................................................................................................................................................... 1 22 1.2 Scope and Application ................................................................................................................................... 1 23 1.3 Guiding Principles ......................................................................................................................................... 1 24 1.4 Background .................................................................................................................................................... 2 25

    2 Annual Summary Reports ................................................................................................................................. 3 26

    2.1 Preparing and Maintaining Annual Summary Reports .................................................................................. 3 27 2.2 Acceptable Annual Summary Report Format ................................................................................................ 4 28

    2.2.1 Periodic Benefit-Risk Evaluation Report (PBRER) .................................................................................... 4 29 2.2.2 Periodic Safety Update Report (PSUR) ....................................................................................................... 4 30 2.2.3 Annual Summary Report Alternative Format .............................................................................................. 4 31

    2.3 Canadian-Specific Sections ........................................................................................................................... 5 32 2.4 Notifying Health Canada of a Change in the Risks and Benefits of a Health Product .................................. 6 33 2.5 Use of Foreign Reviews ................................................................................................................................ 6 34

    3 Issue-Related Summary Reports ....................................................................................................................... 7 35

    3.1 Acceptable Issue-Related Summary Report Format ...................................................................................... 7 36

    4 Submission Procedures for Annual Summary Reports and Issue-Related Summary Reports ................... 9 37

    4.1 General Considerations .................................................................................................................................. 9 38 4.2 When to Submit an Annual Summary Report or Issue-Related Summary Report to Health Canada ............ 9 39 4.3 Instructions for Submitting Annual Summary Reports and Issue-Related Summary Reports for Drugs ...... 9 40

    4.3.1 eCTD Format Requirements ...................................................................................................................... 10 41 4.3.2 Non-eCTD Format Requirements .............................................................................................................. 10 42

    4.4 Cover Letter ................................................................................................................................................. 10 43 4.5 Health Canadas Review of Annual Summary Report and Issue-Related Summary Report Submissions .. 10 44 4.6 Status Requests ............................................................................................................................................ 11 45

    Appendix 1: Requirements for Lower Risk Health Products (e.g., certain over-the-counter (OTC) 46 drugs and natural health products) ......................................................................................................................... 13 47

    Appendix 2: Regulations Pertaining to Annual Summary Reports and Issue-Related Summary Reports ....... 15 48

    Appendix 3: Glossary ................................................................................................................................................ 19 49

    Appendix 4: Contact Information ............................................................................................................................ 23 50

    Appendix 5: List of Relevant Guidance Documents ............................................................................................... 27 51

    52

  • Guidance Document for Industry - Preparation and Submission of Summary Reports for Marketed Health Products 1

    1 Introduction 53

    1.1 Objectives 54 This guidance document is intended to: 55 56

    define Health Canadas expectations for post-approval regulatory requirements for health products, and; 57 provide an overview of the procedures for submitting annual summary reports and issue-related summary 58

    reports to Health Canada. 59 60 An annual summary report is a comprehensive assessment of all known safety information for a marketed health 61 product. It is prepared by the market authorization holder (MAH) to provide an update on the worldwide safety 62 profile of a health product at defined intervals post-authorization, and submitted to Health Canada upon request. 63 An issue-related summary report is a concise, critical analysis of a specific safety or effectiveness issue that may be 64 related to a health product. It is prepared by the MAH at the request of Health Canada. 65 66

    1.2 Scope and Application 67 This guidance document provides MAHs with information on how to comply with the Food and Drugs Act, the 68 Food and Drug Regulations, and the Natural Health Products Regulations with respect to the preparation and 69 submission of annual summary reports and issue-related summary reports for marketed health products. 70 71 The principles and practices outlined in this document apply to the following health products for human use: 72 73

    pharmaceutical drugs (prescription and non-prescription drugs, including generics); 74 biologics; 75 biotechnology products; 76 radiopharmaceuticals; 77 preventative vaccines; 78 therapeutic vaccines; 79 natural health products; and, 80 medical devices (when part of a combination product submission). 81

    82 This guidance document does not apply to annual summary reports provided to pre-market Directorates as part of a 83 submission. 84 85 While these principles can be applied across all product lines, please see Appendix 1 for certain products that are 86 within the scope of lower risk health products (e.g., certain over-the-counter (OTC) drugs and natural health 87 products). 88 89

    1.3 Guiding Principles 90 Health Canad

Search related