Draft guidance on management of rolling reviews for drug submissions: Overview

This guidance is a draft version for consultation purposes only. It is not to be implemented at this time.

On this page

• Purpose
• Background
• Scope and application
• Policy objectives
• Transparency
• Note about guidance documents in general

Purpose

This guidance helps sponsors interpret amendments to the Food and Drug Regulations (regulations) that allow a sponsor to apply for rolling review status for a forthcoming drug submission that meets specific eligibility conditions. Guidance is also provided on the review process for these types of drug submissions.

Sponsors of drug submissions for certain vaccines are eligible for a rolling review without having to apply for rolling review status prior to filing. These vaccines are listed in the List of Influenza Vaccines for Which Supplements to New Drug Submissions Can Be Filed.

Rolling review status allows a sponsor to file a drug submission with some but not all of the information necessary for Health Canada to assess the proposed drug’s safety, efficacy and quality. After filing the drug submission, the sponsor has a set period of time to provide the missing information.

Eligibility for rolling review does not change the safety, efficacy and quality requirements outlined in Part C of the regulations.

This guidance:

• outlines Health Canada’s expectations for rolling review submissions
• provides a consistent interpretation of the provisions in the regulations that pertain to rolling reviews
• clarifies the process by which a sponsor may apply for rolling review status for a forthcoming drug submission
• gives information about the rolling review process and the requirements after an application has been approved and a drug submission has been filed

Background

Health Canada has previously used rolling reviews to support timely access to drugs that reduce the risk of certain significant infectious diseases.

Rolling reviews have been available by policy for annual strain updates of human influenza vaccines and for the simultaneous review of veterinary drugs with the United States under the Regulatory Cooperation Council. Rolling reviews are also available in law for new drug submissions for designated COVID-19 drugs.

Due to the time constraints associated with annual strain updates of influenza vaccines, Health Canada has allowed sponsors to provide the required information for these updates in a rolling manner after filing their drug submission. Filing is made in accordance with the Annual update of seasonal influenza vaccines guidance document.

During the COVID-19 pandemic, Health Canada amended the regulations to maintain some of the modified requirements introduced through the Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19. This included enabling rolling reviews specifically for COVID-19 drugs.

Based on our experience with rolling reviews, we are now giving sponsors an option to submit some of the required information after the filing of an eligible drug submission. Sponsors must submit the missing information within a specified time period after filing their submission, provided Health Canada has granted rolling review status to that submission.

The required information that is outstanding at the time of filing is referred to as “missing information” in the regulations and in this guidance document.

Scope and application

This draft guidance document is for sponsors:

• who want to apply to Health Canada for rolling review status for a forthcoming drug submission
• who have filed a drug submission that has been granted rolling review status

The draft guidance document also applies to the rolling review of drug submissions related to vaccines listed in the List of Influenza Vaccines for Which Supplements to New Drug Submissions Can Be Filed. This type of review allows sponsors to provide some of the information required to assess the safety, efficacy and quality of the proposed drug after they have filed their submission.

The scope of this guidance document includes drugs for human and veterinary use. The Health Products and Food Branch regulates these in accordance with the Food and Drugs Act (act) and its regulations.

This guidance document does not apply to the following submissions:

• drug submissions eligible for a rolling review for a public health emergency drug for COVID-19 or a condition described in the List of conditions that threaten public health in Canada
  • for more information, please refer to the Guidance on the Food and Drug Regulations for public health emergency drugs
• veterinary drug submissions undergoing joint or simultaneous reviews with foreign regulatory authorities
  • for more information, please refer to the country-specific simultaneous review guidance for veterinary drug submissions

The rolling review option outlined in this guidance document does not apply to the following:

• abbreviated new drug submission (ANDS) pathway
• supplement to an abbreviated new drug submission (SANDS) pathway
• submission classes with a performance standard of 120 days or less

Policy objectives

The objectives are to:

• provide an option allowing for specified information required for an eligible new drug submission (NDS) or supplement to a new drug submission (SNDS) to be provided to Health Canada after the submission has been filed
• help resolve issues early during the rolling review process and provide more opportunities for interaction with the regulator about their submission
• facilitate access to the Canadian market earlier provided the evidence requirements for safety, efficacy and quality have been met

Transparency

Health Canada’s transparency initiatives for human drugs remain in place for drug submissions eligible for a rolling review.

Health Canada will continue to communicate up-to-date information about drugs for human and veterinary use. You can find the following information online:

• Submissions with a rolling review status that have been issued a screening acceptance letter appear in the lists for drug and health product submissions under review.
• NOC database: contains NOCs issued for drugs for human and veterinary use.
• Drug product database: contains information about DINs issued for drugs for human and veterinary use, including the product monograph for human drugs and the product labelling for veterinary drugs.
• Drug and Health Product Portal: contains regulatory decision summaries and summary basis of decision documents, which describe Health Canada's rationale for the approval of prescription drugs for human use.
• Clinical information portal: contains the clinical information filed by sponsors to seek approval of human drugs under Division 8 of the FDR.

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, 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 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 the regulations and other applicable guidance documents.