Health Canada, through its Clinical Trials Database, is providing to the public a listing of specific information relating to phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs. [from website]

Health Canada's Clinical Trials Database is a listing of information about phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs. Additional information on Health Canada’s CTD is available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/health-canada-clinical-trials-database/frequently-asked-questions.html

BackgroundThis study examined multiple aspects about the approval of new drugs: the characteristics of the drugs, the quality and quantity of information that Health Canada discloses about the demographics of patients enrolled in clinical trials, the characteristics of the trial, and the type of review that it uses. It examines whether there have been changes in these measures between 1 September 2012 and 31 March 2022.MethodsA list of all new drugs approved, type of review used, and drug characteristics was generated from Health Canada annual reports. Therapeutic categories were identified from the World Health Organization Collaborating Center for Drugs Statistics Methodology. The Summary Basis of Decision documents of Health Canada were used to identify patient demographics in clinical trials and clinical trial characteristics.ResultsHealth Canada approved 326 new drugs for 407 indications. The percent of orphan drugs approved increased from 35.6 to 51.3%. The number of indications per drug decreased (p = 0.0817) as did the number of pivotal trials per drug (p = 0.0091). The percent of Phase 3 trials dropped from 76.3% in 2012–2015 to 64.8% in 2019–2022 (p = 0.005). There was also a statistically significant decrease in the percent of trials that were randomized, controlled, and blinded. The clinical trial characteristics of orphan drugs and the type of review used were both significantly different compared with non-orphan drugs. The percent of trials which had information about the number of patients enrolled, the percent of trials that provided the age of the patients, and the sex breakdown all significantly increased.ConclusionThe results show that there has been a change in regulatory standards that may be due to them becoming less rigorous, because of an adaptation to the number of orphan drugs being submitted or a combination of both reasons. At the same time, there has been some improvement in the transparency of data. Health Canada has recently embarked on a series of reforms in drug regulation and clinical trial management. These changes need to be closely evaluated to be sure that they enhance the efficacy and safety of new drugs.

Health Canada has authorized certain clinical trials in patients in Canada. Our public Clinical Trials Database is a public listing of specific information relating to these trials. Additional publicly accessible registries that further support finding suitable trials are: ClinicalTrials.gov and Current Controlled Trials International Standard Randomized Controlled Trials Number Register.

Sponsors of COVID-19-related drug and vaccine clinical trials can choose between 2 different processes: existing process outlined in the Food and Drug Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

Objectives: This study examines the characteristics of studies that Health Canada uses to grant full marketing authorization for products given a conditional approval between January 1, 1998 and June 30, 2017.

Design: Cohort study.

Data sources: Journal articles listing drugs that fulfilled their conditions and received full marketing authorization, Notice of Compliance database, Notice of Compliance with conditions web site, Qualifying Notices listing required confirmatory studies, clinicaltrials.gov, PubMed, Embase, companies making products being analyzed, journal articles resulting from confirmatory studies.

Interventions: None

Primary and secondary outcome measures: Characteristics of studies - study design (randomized controlled trials, observational), primary outcome used (clinical, surrogate), blinding, number of patients in studies, patient median age, number of men and women.

Results: Eleven companies confirmed 36 publications for 19 products (21 indications). T...

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices. Authorization is done through the Medical Device Regulations or the Interim Order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

Health Canada (HC) and the Canadian Institutes of Health Research (CIHR), with the collaboration and participation of the Canadian Association of Research Ethics Boards (CAREB), recognize the urgent need to conduct clinical trials to evaluate the safety and efficacy of a drug, a vaccine or a medical device in treating, preventing, mitigating or diagnosing COVID-19.

This statement provides guidance to clinical trial applicants about the investigational use of marketed drugs within clinical trials in Canada.

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices. Authorization is done through the Medical Device Regulations or the Interim Order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

Health Canada has authorized certain clinical trials in patients in Canada. Our public Clinical Trials Database is a public listing of specific information relating to these trials. Additional publicly accessible registries that further support finding suitable trials are: ClinicalTrials.gov and Current Controlled Trials International Standard Randomized Controlled Trials Number Register.

Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing outlined in the Medical Devices Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

This Notice serves to inform clinical trial sponsors that Health Canada will publish information about all clinical trial applications (CTAs) authorized as of April 1, 2013, for the study of drugs in patients.

Health Canada (HC) and the Canadian Institutes of Health Research (CIHR), with the collaboration and participation of the Canadian Association of Research Ethics Boards (CAREB), recognize the urgent need to conduct clinical trials to evaluate the safety and efficacy of a drug, a vaccine or a medical device in treating, preventing, mitigating or diagnosing COVID-19.

This manual is based on Health Canada's Guidance for Clinical Trial Sponsors: Clinical Trial Applications and other applicable guidance documents. It is designed to provide tools and relevant links in order to facilitate the successful filing of a Clinical Trial Application (CTA) to Health Canada.

Guidance documents for management of drugs for clinical trials involving human subjects. The sponsor must ensure that the clinical trial is conducted in accordance with the requirements of the protocol, which has been authorized by Health Canada and approved by REB(s).

📍 Overview

The Drug Product Database (DPD) is the official registry of all pharmaceutical products that are authorized for sale in Canada. Maintained by Health Canada, this dataset provides comprehensive information on drugs that are currently approved, previously approved (but discontinued or withdrawn), or under specific regulatory conditions.

This dataset is a crucial resource for researchers, healthcare professionals, regulators, and data scientists working in public health, pharmacovigilance, healthcare analytics, and regulatory intelligence.

💊 About the Dataset

The Drug Product Database (DPD) contains details about:

• Active and previously authorized human and veterinary drug products sold in Canada
• Product names, dosage forms, routes of administration, and strengths
• Regulatory status, Drug Identification Number (DIN), and approval information
• Companies responsible for manufacturing and marketing
• Therapeutic classifications and pharmaceutical standards

Each record represents a single drug product as listed in Health Canada’s public DPD.

📂 Dataset Contents

📊 Example Use Cases

Here are some ideas for how you can use this dataset:

• 🩺 Drug trend analysis: Track how the number of authorized drug products changes over time.
• 🧪 Therapeutic class exploration: Explore the most common therapeutic categories or emerging treatment areas.
• 🧬 Active ingredient analysis: Identify commonly used active ingredients and their distribution across products.
• 🏥 Regulatory lifecycle studies: Study product approvals, discontinuations, and regulatory trends.
• 🤖 ML projects: Build models to predict drug approval likelihood, classify therapeutic categories, or cluster similar drugs.

📈 Potential Visualizations

• Top 10 companies by number of authorized drugs
• Distribution of dosage forms and routes of administration
• Time-series visualization of drug approvals per year
• Network graphs linking active ingredients to therapeutic classes
• Sankey diagrams of status transitions (e.g., Approved → Marketed → Discontinued)

🧠 Why This Dataset Matters

Drug regulation and market authorization are key aspects of public health. This dataset enables:

• Transparency in regulatory processes
• Data-driven insights into Canada’s pharmaceutical landscape
• Academic research on drug safety, market dynamics, and healthcare policy
• Industry intelligence for pharmaceutical R&a...

Guidance documents for management of drugs for clinical trials involving human subjects. The sponsor must ensure that the clinical trial is conducted in accordance with the requirements of the protocol, which has been authorized by Health Canada and approved by REB(s).

Guidance for applicants seeking authorization to conduct COVID-19 drug clinical trials.

Pharmacometrics is the science of using quantitative analysis and modelling and simulation (M&S) approaches to inform and enhance drug development and regulatory review. Pharmacometrics also encompasses quantitative system pharmacology and model-informed drug development (MIDD) approaches.