The Drug Product Database (DPD) system captures information on Canadian human, veterinary and disinfectant products approved for use by Health Canada. To facilitate the use of the drug product data, multiple Drug Product files are available. Users can access the complete data set through the “Drug Product” file. Subsets of the data can be accessed in the “Drug Product By …” files. The data in these files are filtered based on the current drug product status. For example, only drug product data for Approved products will be found in the “Drug Product By Approved Status” file.

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.

The Drug Product Database (DPD) system captures information on Canadian human, veterinary and disinfectant products approved for use by Health Canada. To facilitate the use of the drug product data, multiple Drug Product files are available. Users can access the complete data set through the “Drug Product” file. Subsets of the data can be accessed in the “Drug Product By …” files. The data in these files are filtered based on the current drug product status. For example, only drug product data for Approved products will be found in the “Drug Product By Approved Status” file.

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)

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...

Unfortunately, the text-based data extract is no longer accessible through the Natural and Non-prescription Health Products (NNHPD) website. We want to underline that the support for the CSV (text) extract formats has been dropped by our program area and the links to CSV files on the page will be deleted soon. However, the alternative formats XML and JSON are both available and are updated daily and will continue to be moving forward. .For the most recent LNHPD extract you can retrieve either XML or JSON extracts from our API. We apologize for any confusion this may have caused. The Licensed Natural Health Products Database contains information about natural health products that have been issued a product licence by Health Canada. This data extract contains information on NHP Products. Products with a licence have been assessed by Health Canada and found to be safe, effective and of high quality under their recommended conditions of use. You can identify licensed natural health products by looking for the eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label.

Before a drug is authorized for sale in Canada, it must be issued a DIN in accordance with the Food and Drug Regulations. Also in accordance with the Food and Drug Regulations, a manufacturer of a drug must annually, before October 1, notify Health Canada that the drug is still on the market and that all the information previously provided pertaining to the drug is correct. The Health Products and Food Branch (HPFB) commits to service delivery standard of 120 calendar days, from the receipt of annual notification, to update the Drug Product Database (DPD).

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.

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

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.

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).

These documents give information that will help you understand regulated inspections processes. It gives you access to information about each type of drug and health product inspection done by Health Canada, in Canada and abroad.

A nonprescription drug labelling standard outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof. Labelling standards are developed for drugs that have a well characterized safety and efficacy profile under specific conditions of use.

This guidance is intended to harmonize and to update the prescribing information for nonsteroidal anti-inflammatory drugs () indicated for controlling pain and inflammation associated with rheumatic diseases and other less severe conditions. Each Product Monograph is expected to contain objective, adequate and concise information on properties common to the active component and specific to the drug product. It should provide guidance on the safe and effective use of the drug, not only to the practitioner but also to the patient.

The Licensed Natural Health Products Database contains information about natural health products that have been issued a product licence by Health Canada. This data extract contains information on NHP Products.

Products with a licence have been assessed by Health Canada and found to be safe, effective and of high quality under their recommended conditions of use. You can identify licensed natural health products by looking for the eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label.

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). Twenty-nine out of the 36 studies were randomized controlled trials (RCTs) but only 10 stated if they were blinded. Twenty used surrogate outcomes. The median age of patients was 56 (interquartile range (IQR) 44, 61). The median number of men per study/trial was 184 (IQR 58, 514) versus women - 141 (IQR 46, 263).

Conclusions: Postmarket studies required by Health Canada had more rigorous methodology than those required by either the Food and Drug Administration or the European Medicines Agency. There were still deficiencies in these studies. The absence of blinding in the majority of RCTs may introduce bias in their results. The use of surrogate outcomes especially in oncology trials means that improvements in survival are not available. The relatively young age of patients, even for products for cancer, means that predicting how the elderly will respond is often unknown. The almost universal finding that men outnumbered number women may make it hard to differentiate responses by sex. These results raise potential concerns about the quality of evidence that Health Canada accepts.

Service Delivery Standards.

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.