Guidance on evaluation fees for human drugs and disinfectants: Overview
Health Canada has recently updated the Guidance document on fees for the review of human and disinfectant drug submissions and applications. The revised guidance takes effect on March 19, 2021. This updated document replaces the original guidance, which was adopted in May 1997.
On this page
- Background
- Introduction
- Objective
- Policy statements
- Scope and application
- Note about guidance documents in general
Background
As of March 18, 2021, Health Canada will make changes to the Food and Drug Regulations to facilitate the normalization of COVID-19 drugs. The changes affect the following sections:
- scope and application
- mitigation measures
- missed performance standards
We have revised this guidance to include the new fees and revised fee policy.
Previous changes to the guidance have included:
- updating the address for accounts receivable (November 20, 2015)
- making an administrative change to mitigation measures during an urgent public need (November 9, 2015)
- updating and adding examples to sections 2.3.2.8 and 2.3.2.9 to reflect labelling, packaging and brand names of drugs for human use amendments to the Food and Drug Regulations (June 13, 2015)
This guidance document came into effect on April 1, 2020, and should be used for submissions and applications submitted on or after April 1, 2020. For previous versions of this document, please email us at publications-publications@hc-sc.gc.ca.
Introduction
Before a human or disinfectant drug is authorized for sale in Canada, scientific evidence of its safety, efficacy and quality must be provided to Health Canada. This is a requirement of the Food and Drugs Act and Regulations. Health Canada reviews the evidence to determine whether the benefits associated with the product outweigh the risks.
We charge industry fees for these pre-market regulatory activities to recover some of the associated costs.
Objective
This document provides guidance on how fees for the review of human and disinfectant drug submissions and applications will be administered. Fees are in accordance with the Food and Drugs Act and are stipulated in the:
- Fees in Respect of Drugs and Medical Devices Order
- Regulations Amending and Repealing Certain Regulations Made under the Financial Administration Act
Policy statements
Sponsors submitting human or disinfectant drug submissions or applications will be charged a fee. Fees are in proportion to the type and complexity of the regulatory activity.
Unpaid fees are subject to collection procedures in accordance with the federal government’s directive on public money and receivables. Health Canada has the authority to withhold services, approvals or rights and privileges for unpaid fees.
New fees came into effect on April 1, 2020. For further details, see the page on applicable fees.
In addition, Health Canada may:
- waive or reduce fees in specific circumstances (see the section on mitigation measures) for:
- small businesses
- certain products for urgent public health need
- publicly funded health care institutions
- federal, provincial or territorial governments
- submissions for a COVID-19 drug for which an application was previously filed under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 for the same product
- charge a reduced fee or credit a portion of the fee to the sponsor's account in the event that a performance standard is missed (see the page on missed performance standards)
Under the revised fee policy, we will also no longer:
- defer fees for sponsors that have not completed their first full fiscal year of business
- reduce fees for sponsors based on a product’s gross revenue
However, we will honour existing terms and conditions previously granted on fee remissions.
Scope and application
This guidance applies to sponsors submitting a:
- new drug submission (NDS)
- supplement to a new drug submission (SNDS)
- abbreviated new drug submission (ANDS)
- supplement to an abbreviated new drug submission (SANDS)
- drug identification number (DIN) application
Any other type of submission or application is excluded, as well as:
- an extraordinary use NDS filed under C.08.002.01
- an abbreviated extraordinary use NDS filed under C.08.002.1 of the Food and Drug Regulations
- a natural health product
- a drug for veterinary use only (see the guidance related to the management of regulatory submissions)
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 guidance should be read in conjunction with the relevant sections of other applicable guidance documents.
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