Guidance on management of drug submissions and applications: Overview

Download in PDF format
(1.3 MB, 64 pages)

Published: 2025-10-01

Note: Management of applications for biocides and disinfectants

All applications submitted under the Biocides Regulations on or after May 31 2025 must adhere to the Guidance on the Management of Biocide Applications.

During the 4-year transition period (until May 31, 2029), post-authorization changes for disinfectants authorized under the Food and Drug Regulations (FDR) that have not yet transitioned to the Biocides Regulations must be submitted in accordance with this guidance document (Management of drug submissions and applications).

If you have any questions, contact the Natural and Non-prescription Health Products Directorate at nnhpd-dpsnso@hc-sc.gc.ca.

Effective date: October 1, 2025
Replaces: Guidance Document: Management of Drug Submissions and Applications (August 2, 2022)

Document change log

Date	Change	Nature of and reason for change
October 1, 2025	Added public health emergency drugs	Regulatory amendments
	Updated contact information (physical and email addresses)	Administrative
	Removed cost recovery hold	Administrative
August 2, 2022	Removed the submission certification requirement for: response to SDN response to NOD response to NON	Policy change
	Defined the duration of a “response to clarification request”	Administrative
	Updated email addresses, removed physical addresses and added Pharmaceutical Drugs Directorate contact information (formerly Therapeutic Products Directorate)	Administrative
	Increase in performance standard for a post-authorization Division 1 change (PDC-prescription) for prescription pharmaceuticals and those administered or obtained through a health professional in the Pharmaceutical Drugs Directorate includes a screening and review component Separated post-authorization Division 1 change (PDCs) into: PDC-prescription PDC-non-prescription PDC-disinfectant	Policy change
July 7, 2021	Included joint reviews with other regulatory authorities in pause-the-clock mechanism	Policy change
November 26, 2020	Made changes to reflect the new names of the bureaus in the Marketed Health Products Directorate (MHPD)	Administrative
	Made changes to reflect the new Medical Devices Directorate (MDD)	Administrative
	Corrected the email address for questions about the classification of products at the device-drug interface to drug.device.classification-drogue.instrument@hc-sc.gc.ca	Administrative
November 8, 2019	Deleted: notifiable changes safety (90 days) and safety (120 days) New fee categories for: labelling only (generic) and safety updates to labelling (each with a 120-day performance standard) labelling only (disinfectants) with a 90-day performance standard Eliminated fee categories for: published data and Rx to OTC switch Revised performance standard for: labelling only for Division 1 (180 to 120 days) and for Division 8 (60 to 120 days) DINA, DINF and DIND labelling standard (45 to 60 days) Added: screening 1, 2 and review 2 timelines for existing and new fee categories where none previously existed information on the pause-the-clock mechanism	New fees along with a revised fee policy on April 1, 2020, will require significant changes to the guidance document
July 25, 2019	Reorganized and reformatted information to reflect current procedures (with no change to existing practices)	Administrative
	Added: a section on the classification of a therapeutic product an appendix indicating the individual responsible for signing decision documents an appendix listing relevant guidance and policy documents	New information to help sponsors prepare and file drug submissions and applications
	Deleted: update notices final data safety information advance notice letters issuance of acknowledgment letters upon receipt of information by OSIP	Sections deleted from the previous version because no longer used or applicable
	Other changes: Amended the existing 15-day standard timeline for response to a clarification request during scientific review based on the type and performance standards of the submission or application Reorganized the target performance standards table (Appendix 3) to delete replication of classes or types of submissions and applications filed	Administrative
December 19, 2013 (posted December 19, 2013)	Replaced references to Schedule F with references to the Prescription Drug List	Changes to reflect an amendment to the Food and Drug Regulations that replaced Schedule F with the Prescription Drug List

Purpose

This guidance document gives direction and guidance when managing information submitted in accordance with the Food and Drugs Act and its regulations. This guidance is for sponsors and Health Canada staff from the following directorates and divisions:

Medical Devices Directorate (MDD)
Pharmaceutical Drugs Directorate (PDD)
Marketed Health Products Directorate (MHPD)
Business Facilitation and Modernization Directorate (BFMD)
Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
Office of Submissions and Intellectual Property (OSIP) within MHPD
Non-Prescription Drug Evaluation Division (NDED) of the Natural and Non-prescription Health Products Directorate (NNHPD)

Scope and application

This guidance document applies to the following drug submission and application types:

clinical trial application (CTA) and amendments to a clinical trial application (CTA-A)
- applies only to clinical trials filed under Division 5 of the Food and Drug Regulations
- for clinical trials filed under the Natural Health Products Regulations, consult the Guidance document: Clinical trials for natural health products
new drug submission (NDS)
supplement to a new drug submission (SNDS)
abbreviated new drug submission (ANDS)
supplement to an abbreviated new drug submission (SANDS)
extraordinary use new drug submission (EUNDS)
supplement to an extraordinary use new drug submission (EUSNDS)
abbreviated extraordinary use new drug submission (EUANDS)
supplement to an abbreviated extraordinary use new drug submission (EUSANDS)
supplement to a new drug submission - confirmatory (SNDS-c)
supplement to an abbreviated new drug submission - confirmatory (SANDS-c)
new drug submission for disinfectant products (NDS-D)
supplement to a new drug submission for disinfectant products (SNDS-D)

This guidance document also applies to the following:

application for a drug identification number (DIN) for a pharmaceutical product, including non-prescription products attesting to a labelling standard (DINA)
application for a DIN for a category IV monograph product (DINF)
application for a DIN for a biological product (DINB)
application for a DIN for a disinfectant product (DIND)
notifiable change (NC) (for human biologic or radiopharmaceutical drug quality changes)
post-authorization Division 1 change for a pharmaceutical product (PDC) (includes prescription, non-prescription or disinfectant PDCs)
- consult the Guidance document: Post-drug identification number (DIN) changes
post-authorization Division 1 change for a biologic drug product (PDC-B)
- consult the Guidance document: Post-notice of compliance (NOC) changes: Quality
development safety update reports (DSUR)
- when provided to PDD, BRDD and NNHPD as a standalone document and not as part of a submission

Note: This guidance document does not apply to blood establishment submissions and submissions for annual updates of influenza vaccines. For information on managing these submission types, consult:

Post-market pharmacovigilance monitoring documents

The following documents are not within the scope of this guidance but are part of post-market pharmacovigilance monitoring:

annual summary report in any format, including:
- periodic benefit-risk evaluation report (PBRER-PV)
- periodic benefit-risk evaluation report – confirmatory (PBRER-C)
- periodic safety update report (PSUR-PV)
- periodic safety update report - confirmatory (PSUR-C)
issue-related summary report (IRSR-PV)
notification of foreign action (NFA-PV)
patient safety/advertising ad-hoc post-market request (PSA-PV)
post-authorization commitments (PA-PV)
post-authorization act and regulations (REG-PV)
risk communication (RC-PV)
stand-alone submission of a risk management plan (RMP-PV)
- such as RMPs that are not provided with a drug submission or application applicable to this guidance

Send:

these types of documents to the Office of Submissions and Intellectual Property (OSIP)
- OSIP will notify the appropriate Health Canada division or directorate
content-related questions on post-market pharmacovigilance monitoring to the Regulatory Project Management Office in the MHPD

Policy objectives

The objective of this guidance document is to ensure that submission and application information as well as procedures related to a drug review are applied consistently. It gives specific direction and guidance on:

processes and procedures to be followed for managing a drug submission or application
ways to share information, such as through pre-submission meetings
related guidance documents, policies and other relevant information
performance standards for processes

Background

The first major revision to this guidance document was in 1993. It was then updated as follows:

in 2013, to reflect an amendment to the Food and Drug Regulations that replaced Schedule F with the Prescription Drug List
in July 2019, to reflect the most current information, processes and procedures to be used by sponsors and Health Canada staff in managing a drug submission or application
in November 2019, to reflect new fee categories and performance standards as a result of the Fees in Respect of Drugs and Medical Devices Order coming into force on April 1, 2020

Accessing your application

Drug Submission Tracking System - industry access

You may access information on your own submissions or applications using the Drug Submission Tracking System - Industry Access (DSTS-IA). You will be assigned a user name and password.

Information available through this system includes:

submission or application details such as dossier ID, control number (appears as submission number), submission type, submission class, file number, lead reviewing bureau, filing date
drug product information (product name, manufacturer, active ingredients)
status history (such as Screening 1 or Review 1, status dates, target dates)
document history (document type, issued or received) and document date
review (assessment) history such as type of review (for example, clinical, chemistry and manufacturing, label), the status (for example, pending, active) and dates

To obtain a DSTS-IA account or information about industry access, you should email OSIP at client.information@hc-sc.gc.ca .

Status requests

To check the status of your submission or application, you should first access the DSTS-IA. If you have further questions about the status, you may contact the appropriate office or person:

Office of Regulatory Affairs for BRDD or
regulatory project manager for PDD and NNHPD

For CTAs and CTA-As, status updates will not be provided given the short performance standards for review.

Note about guidance documents in general

Guidance documents are meant to 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.

Sponsors should refer to the most up-to-date versions of the guidance documents. The guidance documents are a starting point only to help sponsors.

Page details

2025-10-01

Language selection

Search