Guidance on preparing and submitting summary reports for marketed drugs and natural health products: Overview

On this page

• Scope and application
• Objectives
• Background
• Note about guidance documents in general

Scope and application

This guidance document helps market authorization holders (MAHs) and licence holders prepare and submit annual summary reports for drugs and natural health products, interim summary reports for Natural Health Products or issue-related summary reports for drugs that comply with the following:

• Food and Drugs Act (FDA)
• Food and Drug Regulations (FDR) or
• Natural Health Products Regulations (NHPR)

An annual summary report (ASR) is a comprehensive assessment of all known safety information for a marketed drug or natural health product (NHP). It provides an update on the worldwide safety profile at defined intervals throughout the post-authorization life cycle of the drug or NHP.

An interim summary report (ISR) is a concise and critical analysis of specified safety information for an NHP since the date of the most recent annual summary report.

An issue-related summary report (IRSR) is prepared upon Health Canada's request and contains a concise, critical analysis of a specific safety or effectiveness issue concerning a marketed drug, based on an analysis of adverse reaction reports.

The principles and practices outlined in this guidance document apply to the following products for human use:

• pharmaceutical drugs
  • includes prescription and non-prescription drugs
• biologics as set out in Schedule D to the act
  • includes biotechnology products, vaccines and fractionated blood products
• radiopharmaceutical drugs as set out in Schedule C to the act
  • excludes positron-emitting radiopharmaceuticals used in a study
• natural health products (NHPs) as defined in Section 1 of the NHPR
• combination products (drug and device)

Blood and blood components, cells, tissues and organs, biocides and sperm and ova are beyond the scope of this guidance.

Objectives

This guidance document provides:

• clarity on the expected content and format of ASR, ISR and IRSR
• an overview of the submission of such reports, including procedures for submitting to Health Canada
• clarity concerning the notification, without delay, of significant changes

Background

According to the World Health Organization (WHO), pharmacovigilance is "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem". This activity takes place throughout the lifecycle of a product, which is before, during and after marketing.

Health Canada expects industry to follow good vigilance practices (GVP), and we monitor compliance. An integrated approach that includes multiple information sources; documented and validated processes; and timely reporting to Health Canada is critical.

Responsibility for the safety of marketed drugs and NHPs in Canada is shared. MAHs and licence holders are responsible for the safety of their products throughout their life cycle and must comply with all Canadian legislative and regulatory requirements. Health Canada is responsible for enforcing Canadian legislative and regulatory requirements and monitoring risks associated with marketed products.

In addition to Canadian legislative and regulatory requirements, Health Canada aligns with international best practices wherever possible. As an official member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), we are committed to adopting and implementing ICH guidance such as ICH E2C(R2) Periodic risk-benefit report.

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, alternate approaches to the principles and practices described in this document may be acceptable if they are supported by adequate justification. They 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 always, Health Canada has the authority to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of other applicable guidance documents, as well as the applicable legislation and regulations.