LibGuides: Pharmacy: Drug Regulation

AdisInsight Reports

AdisInsight Reports provide up-to-date information on drug approvals, reactions, and safety amendments.

AdisInsight Reports are published in the journal Drugs and best accessed by navigating to the "Search" bar and searching "AdisInsight Report". If you are searching for a specific drug, you can search the journal for the name of the drug followed by "AdisInsight Report."

AdisInsight Reports are part of Adis' Drug Review Program. In addition to Reports, the program also publishes Drug Evaluations, Q&As and Biosimilar Briefs. Adis Drug Evaluations are published primarily in Drugs, Adis Q&As in Drugs and Therapy Perspectives, and Adis Biosimilar Briefs in BioDrugs.

Drug Safety, Shortages, and Warnings

Canada’s Adverse Drug Reaction Database This link opens in a new window
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products. Adverse reaction reports are submitted by consumers and health professionals, who submit reports voluntarily manufacturers and distributors (also known as market authorization holders), who are required to submit reports according to the Food and Drugs Act

MedEffect Canada
MedEffect Canada provides easy access to drug and health product safety information, including adverse reaction reporting, updated safety information, and quick access to the Adverse Drug Reaction Database.
Health Canada's Advisories, Warnings & Recalls
Up to date information about recalls, advisories and safety alerts for drug, food, and commercial products.
Drug Shortages Canada
Official reporting site for drug shortages and discontinuations in Canada.

EMBASE This link opens in a new window
The Embase database includes pharmacovigilance information through the "PV Wizard" tab in the search options. This feature constructs an adverse reaction search string for you and allows you to set alerts for specific drug adverse reactions.
For more information on how to use this feature, check out the video tutorial on the left.
Additionally, you can use Embase to search for Medical Device information and adverse reactions, and individual Drug information using the respective search tabs.

Regulations & Legislation

Drug Product Database This link opens in a new window
Contains product specific information on drugs approved for use in Canada. The database is managed by the Therapeutic Products Programme and includes human, veterinary and disinfectant products. It contains approximately 20,000 marketed products. Information available in the database includes Brand Name, DIN, Company, Ingredient(s), Route of Administration, Pharmaceutical Form, Package Sizes, Therapeutic Classification, Pharmaceutical Standard and Veterinary Species.

Controlled Drugs and Substances Act, SC 1996, c 19
The legislation that outlines the regulations of controlled drugs in Canada. Drugs included in the Act require a prescription.
NAPRA Drug Schedules
Regulations and conditions for the sale of prescription drugs in Canada.
Compliance and Enforcement: Drugs
Health Canada's compliance and enforcement policies and resources related to drugs.
Compliance and Enforcement: Medical Devices
Health Canada's Medical Devices Compliance Program (MDCP) monitors post-market compliance of medical devices. This includes recalls, shortage reporting, licensing of establishments, and inspections.
NS Pharmacare
NS Pharmacare Programs provides information about Nova Scotia's public drug plans for healthcare providers and the general public.

Drug Companies & Manufacturers

The Drug and Health Product Register
Health Canada searchable database for drugs and medical devices. Provides the manufacturer information, dosage information, and links to any reported adverse effects.
Health Canada Patent Register
Registration of drug and medicinal patents in accordance with the Patented Medicines (Notice of Compliance) Regulations. The database is searchable by medicinal ingredient, brand name, drug ID, or patent number. The database is updated nightly and contains patent-related information on human and veterinary drugs from March 12, 1993 to date.

NexisUni This link opens in a new window
NexisUni is the new interface for Lexis/Nexis Academic. NexisUni provides business and company information (such as: financial information, analyst reports, mergers and acquisitions, SEC filing, etc.)

SEDAR Filings
Access to the most recent corporate filings for Canadian companies.

Business Source Complete This link opens in a new window
"Business Source Complete ... [provides] full text for over 10,000 scholarly business journals and other sources, including full text for more than 1,150 peer-reviewed business publications. Coverage includes virtually all subject areas related to business. This database provides full text (PDF) for more than 350 of the top scholarly journals dating as far back as 1922.
Factiva This link opens in a new window
Provides worldwide full text coverage of local and regional newspapers, trade publications, business newswires, press release wires, media transcripts, news photos, business-rich Web sites,investment analyst reports, market research reports, country and regional profiles, company profiles, historical market data.
Our license specifies that only 6 users may use it at a time. If you are unable to gain access, the license user limit may have been exceeded, please wait a few minutes and try connecting again.

International Drug Regulation Resources

United States

Drug Safety and Availability (U.S. FDA)
United States Food and Drug Administration resources for checking safety and availability of drugs.
Guidance, Compliance, & Regulatory Information (U.S. FDA)
United States Food and Drug Administration resources for the regulation and compliance of drugs.
EDGAR Filings
Access to the SEC's EDGAR (Electronic Data Gathering, Analysis, and Retrieval system) filings by American corporations, funds, and individuals.
FDA Approved Drug Patent Register
FDA-approved drug patents published in the Orange Book. Searchable by ingredient, patent number, administration, and company.

United Kingdom & Europe

United Kingdom - Medicines and Healthcare Products Regulatory Agency
Web page for the Medicines & Healthcare products Regulatory Agency. Includes links for drug safety/warnings and shortages, medical product recalls and alerts, and reporting processes for adverse reactions.
United Kingdom - Guide for Examining Medical Patents
Guide and resources for examining patent applications for medical inventions
European Union - EMA Drug Regulation
European Medicines Agency resources for drug regulation information, including medical devices, compliance, and pharmacovigilance.
European Union - Legal Framework for Medicinal Products
The legal framework governing medicinal products for human use in the EU.

Australia

Australian Drug Safety Information
Department of Health and Aged Care drug safety information page. This page includes links to drug reporting, shortages, recalls, and alerts.
Australian Register of Therapeutic Goods
The Australian Register of Therapeutic Goods (ARTG) lists all therapeutic goods that can be lawfully supplied in Australia. The ARTG includes product name and formulation details, and sponsor (company) and manufacturer details for nearly 100,000 products.