Drug and Medical Device Databases

December 27, 2018

Purpose

The purpose of this document is to provide a comprehensive list of Health Canada’s drug and medical device databases.

These guidelines are designed to facilitate access to these databases and to inform stakeholders on what information is available. These databases include information on prescription and non-prescription pharmaceuticals, biologics and radiopharmaceuticals for use in humans and animals as well as medical devices. This document does not cover databases related to drug products regulated as natural health products.

This document provides a brief overview of the information available in each database. However, it does not provide an in depth description of all the information they contain and their every use. In this document, a link to each database is provided in order to help readers access the databases and to learn more about what the database offers and how to search it.

Background

Health Canada’s drug and medical device databases are intended to increase transparency and to make information accessible to stakeholders and the general public. Although some information on drugs and medical devices can be accessed via alternate channels, Health Canada encourages stakeholders to use the databases as a primary means of accessing information.

Databases

• Drugs
  • Drug Product database
  • Drug and Health Product register
  • Clinical Trials database
  • Submissions Under Review list
  • Drug and Health Products Inspections database
  • Drug Submission Tracking System - Industry Access
  • List of Drugs for an Urgent Public Health Need
  • Notice of Compliance database
  • Notice of Compliance with Conditions listing
  • Prescription Drug list
  • Product Monograph Brand Safety Updates table
• Intellectual property
  • Patent register
  • Register of Certificates of Supplementary Protection and Applications
  • Register of Innovative Drugs
• Side effects, recalls and safety alerts
  • Recalls and Safety Alerts database
  • Canada Vigilance Adverse Reaction online database
• Medical devices
  • Medical Devices Active Licence listing online query
  • Medical Devices Establishment Licence listing

Drugs

Drug Product database

The Drug Product database provides information on drugs authorized for sale in Canada.

Search the database to:

• see if a drug is approved in Canada
• view product monographs for human drugs
• view labels for animal drugs

Learn more about the Drug Product database.

Drug and Health Product register

The Drug and Health Product register provides information on marketed drugs for human use and is the main source of information available to the public about health product safety and use in Canada. This includes information on medical devices, applicable drugs and natural health products.

Search the register to:

• view reported side effects of a drug
• access information on drug use and drug safety
• learn about warnings, precautions and interactions of a drug
• access drug and medical device summary reports including summary basis of decisions and regulatory decision summaries

Learn more about the Drug and Health Product register.

Clinical Trials database

The Clinical Trials database provides information on clinical trials involving human pharmaceutical and biological drugs in patients in Canada.

Search the database to:

• find the sponsor of a clinical trial
• determine the trial status and study population of a clinical trial
• find clinical trials that are relevant to a specific medical condition

Learn more about the Clinical Trials database.

Submissions Under Review list

The Submissions Under Review list provides information about submissions currently under review and certain drug submissions formerly under review.

Refer to the list to:

• make better decisions about your health
• identify substances accepted for review in Canada

Learn more about the Submissions Under Review list.

Drug and Health Products Inspections database

The Drug and Health Products Inspections database provides information on establishment licences and inspections.

Search the database to:

• access information on inspections for the different inspection programs
• view the inspection report card summary of establishments that have been inspected
• learn which establishments for health products are currently licensed or registered in Canada

Learn more about the Drug and Health Products Inspections database.

Drug Submission Tracking System - Industry Access

The Drug Submission Tracking System - Industry Access provides sponsors with access to information about their own drug submissions. Access is granted via user names and passwords.

Sponsors can search the database to view:

• the review target dates of the sponsors submissions
• the screening or review status of the sponsors submissions

List of Drugs for an Urgent Public Health Need

The list of Drugs for an Urgent Public Health Need is a list of drugs not approved for sale in Canada that are allowed to be imported into Canada and sold in the notifying jurisdiction for one year.

Refer to the list to:

• learn what urgent public health needs exist in Canada
• find out if an unauthorized drug is available in Canada for an urgent health need
• find out the intended use or purpose of a drug available in Canada for an urgent health need

Learn more about the list of Drugs for an Urgent Public Health Need.

Notice of Compliance database

The Notice of Compliance database provides Notice of Compliance information on drugs approved for sale in Canada.

Search the database to:

• find out if a drug has received a Notice of Compliance
• find out if conditions associated with a Notice of Compliance with conditions have been fulfilled
• view Health Canada authorization dates for drugs dating back to 1994

Learn more about the Notice of Compliance database.

Notice of Compliance with Conditions listing

The Notice of Compliance with Conditions listing is a list of drugs approved under the Notice of Compliance with conditions policy.

Refer to the listing to:

• find out if a drug is approved under the Notice of Compliance with conditions policy and if conditions have been met
• access related documentation such as qualifying notices and Dear Health Care Professional Letters

Learn more about the Notice of Compliance with Conditions listing.

Prescription Drug list

The Prescription Drug list is a listing of medicinal ingredients that when found in a drug require a prescription. It does not include medicinal ingredients that when found in a drug, require a prescription if those ingredients are listed in the Controlled Drugs and Substances Act Schedules.

The list includes listings of ingredients, their salts and derivatives when appropriate, some examples of these ingredients, any applicable qualifiers, and the date the listing came into effect.

The list has two sections: one that pertains to human use and the other to veterinary use.

Refer to the list to:

• find out if a substance is listed on the prescription drug list, indicating that a drug containing the particular substance requires a prescription to be sold in Canada

Learn more about the Prescription Drug list.

Product Monograph Brand Safety Updates table

The Product Monograph Brand Safety Updates table provides information on updated and new safety labelling changes to the Product Monographs of brand name pharmaceutical drugs. The purpose of this table is to facilitate updates to generic Product Monographs.

Refer to the table to:

• find out if updates have been made to the Product Monograph of a Canadian Reference Product
• if applicable, find out which section(s) of the Product Monograph was updated

Learn more about Product Monograph Brand Safety Updates table.

Intellectual property

Patent register

The Patent register provides patents and Certificates of Supplementary Protection associated with human and veterinary drugs in accordance with the Patented Medicines (Notice of Compliance) Regulations.

Refer to the register to:

• find out if a medicinal ingredient has a patent or a Certificate of Supplementary Protection

Learn more about the Patent register.

Register of Certificates of Supplementary Protection and Applications

The register of Certificates of Supplementary Protection and Applications includes information from Certificates of Supplementary Protection and applications.

Refer to the register to:

• find out the start and end dates of a Certificate of Supplementary Protection term
• learn the application status of a Certificate of Supplementary Protection application

Learn more about the register of Certificates of Supplementary Protection (CSP) and Applications.

Register of Innovative drugs

The register of Innovative Drugs lists human and veterinary drugs that are eligible for data protection and whether the data protection period is active or expired.

Search the register to:

• find out if a medicinal ingredient has data protection and when the data protection ends

Learn more about the register of Innovative Drugs.

Side effects, recalls and safety alerts

Recalls and Safety Alerts database

The Recalls and Safety Alerts database provides access to a comprehensive list of recalls, advisories and safety alerts.

Search the database to:

• find out what recalls and safety alerts have been issued for health products
• find out if a recall or safety alert has been issued for a particular drug and learn about the issue and who is affected

Learn more about the Recalls and Safety Alerts database.

Canada Vigilance Adverse Reaction online database

The Canada Vigilance Adverse Reaction online database contains information on suspected adverse reactions to health products for sale in Canada that happen in Canada.

Search the database to:

• find reports of an adverse reaction to a health product

Learn more about the Canada Vigilance Adverse Reaction online database.

Medical devices

Medical Devices Active Licence listing online query

The Medical Devices Active Licence listing is a database of all medical devices that are offered for sale in Canada or have been licensed in the past.

Search the database to:

• verify the licence status of a medical device
• find product specific information on a medical device
• determine the manufacturer of a medical device and access a list of their device licences

Learn more about the Medical Devices Active Licence listing.

Medical Devices Establishment Licence listing

The Medical Devices Establishment Licence listing provides information on holders of an active medical devices establishment licence.

Search the database to:

• find out which company holds an active establishment licence for a medical device and whether that company distributes, imports or manufactures that device