Guidance for market authorization requirements for COVID-19 vaccines: Overview

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Organization: Health Canada

Date published: 2021-04-13

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COVID-19 is the infectious disease caused by the most recently discovered coronavirus, SARS-CoV-2. This new virus and disease were unknown before the outbreak began in December 2019 and have since spread around the world.

COVID-19 has been known to cause respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, COVID-19 infection can cause pneumonia, severe acute respiratory distress, kidney failure and death. Older people and those with underlying medical problems, such as high blood pressure, obesity, heart problems or diabetes, are more likely to develop serious illness.

The availability of safe, effective and high-quality vaccines will offer a potential means to reduce the spread and severity of disease and address its social and economic consequences.

About this guidance document

This document provides guidance on developing the evidence and documentation needed to obtain an authorization and licensing for importing or selling a COVID-19 vaccine in Canada. This guidance should be read along with the guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19, which explains recent changes to the regulatory process for new COVID-19 drugs.

About market authorizations for a COVID-19 vaccine

Health Canada is committed to helping Canadians protect and improve their health by facilitating access to COVID-19 vaccines that are safe, effective and of high quality. We have introduced amendments to the Food and Drug Regulations to expedite the authorization of COVID-19 drugs, including vaccines, while protecting the health and safety of Canadians.

Vaccine manufacturers seeking to obtain market authorization should consult with us early on and throughout the development process. We are committed to prioritizing the review of any submission seeking authorization of a COVID-19 vaccine.

Health Canada will grant authorizations only if we determine that the benefits of the vaccine outweigh its potential risks. We will base our decision on the evidence provided on the vaccine's safety, quality and efficacy. For vaccines relying on the modified requirements in C.08.002 (2.1) of the Food and Drug Regulations, the risk-benefit analysis weighs the uncertainties about a potential vaccine against the public health need for a vaccine at the time of the decision.

Modified requirements for COVID-19 drugs make it possible for initial authorization, based on early data, while the manufacturer continues working on developing a vaccine. We will use terms and conditions to manage uncertainties or risk mitigation measures related to the vaccine in the context of the public health.

The requirements described in this guidance are a minimum acceptable standard. Health Canada will consider alternate proposals for evidence standards and a rationale for using these standards. As we learn more about the virus and the effectiveness of new vaccines and treatments, we will adjust the evidence requirements as required.

As with all drugs, Health Canada will assess and monitor the quality, safety and effectiveness of all authorized COVID-19 vaccines. We will impose terms and conditions when necessary and take immediate action, if required, to protect the health and safety of Canadians. This action may include suspending or cancelling authorizations or establishment licences.

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 by industry. However, to be acceptable, alternate approaches to the principles and practices described in this document must be 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 reserves the right 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 must make sure 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.

Guidance for implementation

Industry sponsors have been seeking guidance from regulatory authorities on the requirements for developing a COVID-19 vaccine. Guidance has been discussed in pre-submission meetings with Health Canada and other regulators, and through publications following workshops under the International Coalition of Medicines Regulatory Authorities (ICMRA).

Guidance documents have also been published by:

  • the Access Consortium
  • the World Health Organization (WHO)
  • the European Medicines Agency (EMA)
  • the US Food and Drug Administration (US FDA)
  • Japan's Pharmaceuticals and Medical Devices Agency (PMDA)

We continue to work with international regulatory authorities to align requirements for COVID-19 vaccines, where appropriate.

Health Canada's guidance is aligned with these international regulators.

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