This dataset contains complete product information for all approved, marketed, canceled and dormant products for human, veterinary, disinfectant and radiopharmaceutical use in the Canadian Drug Product Database (DPD) as of September 1, 2017. Before drug products are authorized for sale in Canada, Health Canada reviews them to assess the safety, efficacy, and quality. Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.

This dataset contains complete active ingredient information for all approved, marketed, canceled and dormant products for human, veterinary, disinfectant and radiopharmaceutical use in the Canadian Drug Product Database (DPD) as of September 1, 2017. Before drug products are authorized for sale, Health Canada reviews them to assess their safety, efficacy, and quality. Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.

Study design We conducted a cross-sectional study to quantify the number and describe the characteristics of prescription drugs on the Canadian market as of August 23, 2022 with a patient support program defined as services (including but not limited to financial assistance) offered to patients prescribed a specific drug and initiated and funded by the manufacturer. We then conducted a structured content analysis of web-based sources to understand the types and range of supports provided to patients through these programs. We chose to rely exclusively on publicly available data sources to both identify and describe manufacturer-sponsored patient support programs as these are sources currently available to patients when making program enrolment decisions and policymakers seeking to understand the extent and impact of this model of care. Sampling frame Because the European Medicines Association defines a patient support program as services for a specific drug offered by the company holding the marketing authorization, we first sought to identify all drug companies with currently marketed, prescription products in Canada. Between June 27, 2022 and August 23, 2022, two investigators independently extracted the names of all member companies listed on the websites of the three main trade associations for the Canadian pharmaceutical industry (Innovative Medicines Canada, representing the research-based pharmaceutical industry; BIOTECanada, representing the biotechnology industry; and the Canadian Generic Pharmaceutical Association, representing generic drug manufacturers). Because trade association membership is voluntary, we supplemented this list with non-member drug manufacturers identified in previous research. Using the Health Canada Drug Product Database,two investigators independently screened the list of companies and included those with marketed, prescription products and excluded companies that were not drug manufacturers (e.g., law firms) or without currently marketed prescription drugs (e.g., products under development). Discrepancies were resolved through discussion or adjudication by a third author. Sample and variables Using the Health Canada Drug Product Database, one investigator searched each identified drug manufacturer and extracted the product and active ingredient name(s) for all marketed, prescription drugs. We counted a single “drug” as all dosages, formulations, or routes of administration with the same active ingredients and manufacturer since industry patient support programs are brand-specific and do not typically differentiate among these factors. We selected variables that reflect known characteristics of drugs that may be associated with having a patient support program, and for which data were publicly available. One investigator also extracted Schedule D (biologic) status, route(s) of administration, and Level 1 Anatomical Therapeutic Chemical (ATC) code from the Drug Product Database and Product Monograph and identified whether the drug had Orphan Drug Status using the searchable United States database. On the basis of type of Health Canada regulatory review (i.e. innovator or subsequent entry), clinical expertise, and knowledge about the manufacturer, two investigators independently identified the brand status of each drug as brand (i.e. “innovator” products first to market); branded generic (i.e. “subsequent entry” products which are bioequivalent or biosimilar to an existing product on the market, but given a proprietary name); or generic (i.e. “subsequent entry” products which are bioequivalent to an existing product on the market). We classified biosimilars as branded generics. We resolved discrepancies through discussion, and/or adjudication by a third author. Identifying patient support programs and their characteristics Our primary outcome was whether a sampled drug had an associated manufacturer-sponsored patient support program. We defined a patient support program as any combination of services or resources related to medication access, administration, adherence, education, storage, or disposal for patients prescribed a specific product and initiated, sponsored and/or operated by the company holding the product’s marketing authorization. We distinguished patient support programs from “patient assistance programs,” excluding programs that exclusively provided financial assistance (e.g., coupons, co-pay coverage, etc.); expanded or compassionate access programs; risk management programs outlined in the Product Monograph (initiated by the regulator rather than the manufacturer); and programs delivered solely for a clinical study. Two investigators independently performed structured searches on Google (“[company name] AND patient support program AND Canada” and “[drug brand name] AND patient support program AND Canada”) to identify industry sponsored patient support programs in Canada and resolving discrepancies through discussion. Using Zotero, a reference management...

The Canadian Clinical Drug Dataset is a drug terminology and coding system designed to allow the interchange of standardized drug and medical device information between diverse digital health systems. Some use cases include electronic prescribing, electronic medical records, medication reconciliation and analytics. It also provides for the classification and identification of defined groups of medications (called special groupings), such as narcotic and controlled drugs. It has the capacity to be used by knowledge-based vendors, clinicians, researchers, statistical users, government agencies, healthcare organisations and consumers. The data source for the CCDD is the Drug Product Database (DPD) which contains information on drugs approved by Health Canada. However, the data is modeled differently following the CCDD Editorial Guidelines which take into consideration international terminology standards. For example, DPD uses the dosage form, “tablet (delayed-release)”, whereas CCDD uses the equivalent term “gastro-resistant tablet.” The Canadian Clinical Drug Data Set does not replace the Health Canada Drug Product Database (DPD) but is published in addition to it. The scope of health products included in CCDD is limited to those classified as human in DPD (veterinary, radiopharmaceutical and disinfectant products are out of scope). Some exclusions apply within the human class but are subject to periodic review: For a full list of exclusions, please see the Scope section in the CCDD Editorial Guidelines. In addition, a limited number of medical devices that are commonly prescribed and dispensed at a community pharmacy are included. This data set was developed in collaboration with Canada Health Infoway and is also available in their Terminology Gateway at https://tgateway.infoway-inforoute.ca/ccdd.html (Free login required)

COVID-19 and other drug product announcements until July 2023.

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

List of Health Canada information sheets covering topics related to drug products.

Acts and regulations, Health Canada guidance documents and policies related to pharmaceutical drugs and medical devices. The Pharmaceutical Drugs Directorate (PDD) applies the Food and Drug Regulations under the authority of the Food and Drugs Act to ensure that the pharmaceutical drugs offered for sale in Canada are safe, effective and of high quality.

These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada.

This policy describes the requirements relating to the assignment of Drug Identification Numbers (DINs) for drug products sold in kits in accordance with the Canadian Food and Drug Act and Regulations (FDA&R).

The data extract is a series of compressed ASCII text files of the full data set contained in the Canada Vigilance Adverse Reaction Online Database. It is intended for users who are familiar with database structures and setting up their own queries. Find details on the data structure required for the data file in the Canada Vigilance Adverse Reaction Online Database - Data Structure. In order to use the data, the file must be loaded into an existing database or information system provided by the user. The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products, captured from adverse reaction reports submitted to Health Canada by consumers and health professionals, who submit reports voluntarily, as well as by market authorization holders (manufacturers and distributors), who are required to submit reports according to the Food and Drugs Regulations. Information concerning vaccines used for immunization have only been included in the database since January 1, 2011. Indication data has recently been added to the data extract files and the Detailed Adverse Reaction Report. Indication refers to the particular condition for which a health product was taken. For example, diabetes is an indication for insulin. Health products are often authorised for use in treating more than one indication. Note: The database cannot be used on its own to evaluate a health product's safety profile. It does not provide conclusive information on the safety of health products, and is not a substitute for medical advice. Should you have an issue of medical concern, consult a qualified health professional.

Documents on the Summary Basis of Decision (SBD) explain why certain drugs and medical devices were authorized for sale in Canada. Regulatory Decision Summaries (RDS) explain decisions for certain health products seeking market authorization, including medical devices and prescription drugs. A Summary Safety Review (SSR) follows after a potential safety issue with a drug or health product has been identified.

Health Canada uses disaggregated data to analyze the safety and efficacy of health products. The collection and analysis of disaggregated data in clinical trials is key to scientific rigour. This data: confirms that the diversity of clinical trial participants reflects the population groups that will use the product , and is used by sponsors and Health Canada to look at a drug’s safety and efficacy by subpopulation, where feasible. The data may also indicate if we need to verify a product’s safety or efficacy in certain populations through post-market monitoring.

All pharmaceutical products fall into one of three categories. They are: Standard Benefits These benefits include many over-the-counter and prescription drugs, plus medical devices, that are considered by VAC to represent "mainstay" therapies. About 80% of all drug benefits fall into this category and most bear a Drug Identification Number (DIN) assigned by Health Canada. All products on this formulary are readily accessible to eligible clients who have a prescription from their physician or dentist. Special Authorization (SA) Benefits These benefits provide eligible clients with higher level or higher cost therapies approved by VAC as part of a managed health care approach. To access benefits on this formulary, clients will need a prescription and must be able to demonstrate a medical need that is most appropriately met with the requested therapy. Non-formulary Products VAC may approve these items on an exceptional basis provided the client has a medical need and can clearly demonstrate that the product offers specific and necessary therapeutic value in the most reasonable and medically appropriate fashion.

Health Canada uses disaggregated data to analyze the safety and efficacy of health products. The collection and analysis of disaggregated data in clinical trials is key to scientific rigour. This data: confirms that the diversity of clinical trial participants reflects the population groups that will use the product , and is used by sponsors and Health Canada to look at a drug’s safety and efficacy by subpopulation, where feasible. The data may also indicate if we need to verify a product’s safety or efficacy in certain populations through post-market monitoring.

When a company decides it would like to sell a drug or vaccine in Canada, it files a submission with Health Canada. A new drug submission contains detailed scientific information about the drug's safety, efficacy and quality. Health Canada scientific reviewers evaluate data to assess the potential benefits and risks of a drug or vaccine. They also review the information that will be provided to health care practitioners and consumers about the product. After the review, we may authorize the drug or vaccine for sale in Canada only if the benefits of the product outweigh the potential risks.

The Food and Drug Regulations (FDR) contain provisions that help to safeguard the Canadian drug supply. The regulatory provisions are one part of Canada's overall multi-stakeholder toolkit to help prevent and mitigate drug shortages. Compliance and enforcement actions related to these provisions are undertaken as per Health Canada's Compliance and enforcement policy for health products (POL-0001).

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in November 2023 by Health Canada.

This notice is being issued to clarify to drug manufacturers and sponsors that elements of Risk Management Plans (RMPs) required by Health Canada, such as controlled distribution programs, are not intended to restrict access to Canadian Reference Products (CRPs) for generic drug manufacturers for the purposes of conducting comparative testing.

Objectives: Examine the probability of new active substances (NASs) approved in Canada between 1 January 1997 and 31 March 2012 acquiring a serious postmarket safety warning. Design: Cohort study. Data sources: Annual reports of the Therapeutic Products Directorate and the Biologic and Genetic Therapies Directorate; evaluations of therapeutic innovation from the Patented Medicine Prices Review Board and Prescrire International; MedEffect Canada website. Interventions: Postmarket regulatory safety warning or withdrawal from market due to safety reasons. Primary and secondary outcome measures: Compare the probability of acquiring a postmarket safety warning in Canada in four different groups of drugs: (1) traditional medications versus biologics; (2) medications that offer significant new therapeutic benefits versus those that do not. Determine how well the type of review that an NAS received from Health Canada predicted the product's postmarket therapeutic value. Results: The probability of a traditional NAS acquiring a serious safety warning and/or being withdrawn was 29.9% (95% CI 21.8% to 40.2%) vs 27.3% (95% CI 18.2% to 39.7%) for an NAS of biological origin (p=0.47, log-rank test). For medications that were significant therapeutic advances the probability was 40.2% (95% CI 24.5% to 60.9%) vs 33.9% (95% CI 26.4% to 42.7%) for those that were not (p=0.18, log-rank test). Health Canada was 77.4% accurate in predicting the therapeutic importance of an NAS. Conclusions: There was no difference in postmarket regulatory safety action between traditional medications and biologics and no difference between drugs with significant therapeutic benefits and those without. Although these results draw on Canadian data, they are likely to be relevant internationally. Further research should assess whether the current level of premarket safety evaluation is acceptable.