Pharmaceutical Drugs Directorate

The Pharmaceutical Drugs Directorate (formerly the Therapeutic Products Directorate (TPD)) is Canada's regulator of prescription pharmaceutical drugs for human use. Before authorizing a drug for sale in Canada, we verify that it meets the safety, efficacy and quality requirements of the Food and Drugs Act and its Regulations.

On this page

• What we do
• Bureaus and offices
• For more information
• Contact us

What we do

The Pharmaceutical Drugs Directorate (PDD):

• reviews scientific information to assess the safety, efficacy, and quality of a prescription drug
• assesses the potential benefits and risks of a prescription drug
• reviews Clinical Trial Applications (CTAs) for prescription drugs to ensure that the studies are well-designed and that participants will not be exposed to undue risk
• monitors the evolving safety of drugs in development through the review of adverse reaction reports that are submitted as a requirement of the Food and Drug Regulations
• makes non-marketed drugs available to health professionals for patients when conventional therapies have failed, are not suitable, or are not available
• provides Canadians with science-based medical information they need to make informed choices

Bureaus and offices

The Directorate contains 9 offices and bureaus:

• Director General's Office (DGO)
• Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
• Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD)
• Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
• Bureau of Pharmaceutical Sciences (BPS)
• Bureau of Policy, Science and International Programs (BPSIP)
• Bureau of Medical Sciences (BMS)
• Office of Planning, Performance and Review Services (OPPRS)
• Office of Clinical Trials (OCT)

For information on medical devices, please visit the Medical Devices Directorate (MDD) website.

Director General's Office

The Director General's Office approves the sale of prescription drugs, makes regulatory decisions and oversees clinical trials. The office is responsible for:

• managing public relations and answering questions from the public
• communicating with stakeholders in Canada and around the world
• reporting the Directorate's work to senior officials in the Department
• overseeing and directing projects that manage the strategic vision, focus, and priorities of the Directorate and align them to those of the branch, department, and federal government
• coordinating training and development of standard operating procedures, as well as conducting internal quality audits

The Bureaus of Cardiology, Allergy and Neurological Sciences; Gastroenterology, Infection and Viral Diseases; Metabolism, Oncology and Reproductive Sciences; and Medical Sciences all participate in urgent reviews for drugs under investigation by the Regulatory Operations and Enforcement Branch (ROEB). These bureaus share information about health issues and scientific advice with the public and health professionals.

Bureau of Cardiology, Allergy and Neurological Sciences

This bureau performs clinical reviews of prescription drugs that relate to:

• respiratory disorders (including drugs for allergy, cough, asthma, emphysema like antihistamines, antitussives, bronchodilators, corticosteroids)
• cardiovascular disorders (including drugs for blood pressure, heart disease, cholesterol, blood thinning like antihypertensives, blood thinners, cholesterol-lowering medications)
• neurological disorders (including drugs for anaesthesia, pain, depression, psychosis like anesthetics, analgesics, antidepressants, antipsychotics)

Bureau of Gastroenterology, Infection and Viral Diseases

This bureau performs clinical reviews of prescription drugs that relate to:

• viral infections (for example, treatment of Human Immunodeficiency Virus (HIV) infection); pre-exposure prophylaxis of HIV; treatment of hepatitis C and/or B virus infections; prophylaxis and treatment of influenza virus; drugs for pandemic flu, drugs against other viral infections and systemic antifungal agents)
• bacterial, fungal, and parasitic infections, including antimicrobial resistant infections (for example, topical, oral, and intravenous antibiotics and other anti-infective drugs used to treat or prevent mild to severe infections of the ear, eyes, throat, skin, lungs, surgical sites, and other bodily systems)
• gastroenterology (for example, Inflammatory Bowel Disease (IBD); ulcerative colitis and Crohn's disease; Irritable Bowel Syndrome (IBS); chronic constipation/diarrhea; bowel cleansers used prior to colonoscopy; gastro-esophageal reflux disease (GERD); gastric and duodenal ulcers)
• ophthalmics (for example, glaucoma, macular degeneration, diabetic macular edema, dry eye syndrome)
• dermatology (for example, acne vulgaris, rosacea etc.)
• contrast agents used in medical imaging
• Total Parenteral Nutrition (TPN); prescription vitamins
• antidotes

BGIVD also houses the Labelling Division, which performs reviews of the information that is distributed with, or accompanies, the drug. This includes:

• the inner and outer package labels and the package insert
• brand name assessments
• the Consumer Information section of the Product Monograph that explains what the medication is for, how to use it, and what the potential side effects are
• Product Monographs for subsequent entry products

The Administrative Services Unit in the Labelling Division screens submissions filed for manufacturer and/or product name changes eligible for administrative processing that do not contain scientific data.

Bureau of Metabolism, Oncology and Reproductive Sciences

This bureau performs clinical reviews of prescription drugs that relate to:

• obstetrics, gynecology and urology (for example, birth control, intrauterine devices, fertility, bladder control, and sexual dysfunction drugs)
• oncology (for example, tyrosine kinase inhibitors, alkylating agents, hormone antagonists, immunomodulation agents)
• hematology (for example, iron chelating agents and iron supplements)
• metabolic and musculoskeletal disorders (like glucose-lowering, nonsteroidal anti-inflammatory, osteoporosis, psoriasis, rheumatic, and gout drugs, and analogues of somatostatin, thyroid hormone)

Bureau of Pharmaceutical Sciences

This bureau reviews the quality and chemical composition of brand name and generic drugs submitted for approval. The bureau also reviews comparative clinical studies that claim to show the bioequivalence of brand name and generic drugs, to ensure that new versions of the brand name drug are as effective as the original version.

For marketed drug products, the bureau provides advice to:

• Regulatory Operations and Enforcement Branch
• Marketed Health Products Directorate about safety signals related to product quality or bioequivalence

Bureau of Policy, Science and International Programs

This bureau:

• provides statistical consultation services to review bureaus
• ensures that review bureaus have access to scientific advice through committees and panels
• provides support on international files related to prescription drugs
• develops and implements guidance documents and policies
• develops, maintains, and implements policy to support the Directorate's work

Bureau of Medical Sciences

This bureau provides medical review services to the review bureaus that relate to all clinical review areas (in particular, first-in-class drugs and priority review status determinations). It also:

• conducts urgent reviews for drugs under investigation by the ROEB
• shares information about health issues and scientific advice with the public and health professionals and develops strategies for safe use of therapeutic products
• works with related offices outside of the Directorate on issues that come up after a product is allowed to be sold, compliance and enforcement of regulations, and emergency preparedness
• provides urgent reviews for drugs under investigation by the ROEB and helps deal with drug shortages
• manages the Drugs List for the Urgent Public Health Need regulatory pathway

Office of Planning, Performance and Review Services

This office provides corporate support for the Directorate. We deliver project management services and logistical support for the review of scientific drug submissions.

We also:

• hold regular meetings with stakeholder associations
• develop documents supporting pre-market transparency
• provide drug submission pipeline planning and performance measurement
• manage contracts with scientists from outside of the Directorate
• manage finances and funding in the Directorate

Office of Clinical Trials

This office provides clinical and quality (chemistry and manufacturing) reviews of Clinical Trial Applications for prescription drugs and some natural health products and monitors their safety while they are being used in clinical trials. We also review Special Access Program requests for access to non-marketed drugs to treat medical emergencies when conventional therapies have failed, are not suitable, or are not available.

Contact us

Pharmaceutical Drugs Directorate
Director General's Office
Health Products and Food Branch
Address Locator: 3106B
Ottawa, Ontario
K1A 0K9

General Enquiries

E-mail: pharma_drug_enquiries-renseignements_medicaments_pharma@hc-sc.gc.ca
Telephone: 613-957-0368
Fax: 613-952-7756
Teletypewriter: 1-800-465-7735 (Service Canada)

For general enquiries for medical devices, please visit Medical Devices Directorate (MDD)

Bureaus

Offices

Office of Clinical Trials

Special Access Program

For more information

• Drugs and Health Products
• Drug Product Database
• Drug and Health Product Portal
• Notice of Compliance Database