Therapeutic Products Directorate

The Therapeutic Products Directorate (TPD) is Canada's regulator of prescription drugs and medical devices for human use. Before giving permission to sell a product, the directorate must see scientific evidence of the product's safety, effectiveness, and quality, as required by the Food and Drugs Act and Regulations.

On this page

What we do

The Therapeutic Products Directorate:

  • reviews scientific information to assess the safety, efficacy, and quality of a prescription drug or a medical device
  • assesses the potential benefits and risks of product prescription drug or a medical device
  • reviews Clinical Trial applications for prescription drugs and Investigational Testing applications for medical devices to ensure that the studies are well-designed and that participants will not be exposed to undue risk
  • makes non-marketed drugs and medical devices available to health professionals for patients when conventional therapies have failed, aren't suitable, or are not available
  • provides Canadians with science-based medical information they need to make informed choices
  • monitors the evolving safety of drugs in development through the review of adverse reaction reports that are submitted as a requirement of Division 5 of the Food and Drug Regulations

Bureaus and offices

The directorate contains 12 offices and bureaus:

Director General's Office

The Director General's Office (DGO) approves the sale of prescription drugs and medical devices, and oversees clinical trials. As a leader in the directorate, the office is in charge of:

  • managing public relations and answering questions from the public
  • communicating with stakeholders in Canada and around the world
  • reporting the directorates work to senior officials in the department
  • overseeing and directing directorate projects

managing the strategic vision, focus and priorities of the directorate and aligning them to those of the branch, department, and federal government

The Bureaus of: Cardiology, Allergy and Neurological Sciences; Gastroenterology, Infection and Viral Diseases; and Metabolism, Oncology and Reproductive Sciences all participate in urgent reviews for drugs under investigation by the Regulatory Operations and Regions Branch (RORB). These bureaus share information about health issues and scientific advice with the public and health professionals. We also develop strategies for safe use of these therapeutic products.

Bureau of Cardiology, Allergy and Neurological Sciences

The Bureau of Cardiology, Allergy and Neurological Sciences (BCANS) regulates prescription drugs intended for the treatment of:

  • respiratory disorders (including drugs for allergy, cough, asthma, emphysema like antihistamines, antitussives, bronchodilators, corticosteroids etc.)
  • 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 etc.)

Bureau of Gastroenterology, Infection and Viral Diseases

The Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD) performs clinical reviews of prescription drugs in the following areas:

  • HIV medications
  • anti-viral drugs
  • avian flu drugs

Bureau of Metabolism, Oncology and Reproductive Sciences

The Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS) 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, etc.)
  • oncology (for example, tyrosine kinase inhibitors, alkylating agents, hormone antagonists, immunomodulation agents, etc.)
  • 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, etc.)

Bureau of Pharmaceutical Sciences

The Bureau of Pharmaceutical Sciences (BPS) 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:

We also respond to drug shortages by providing expedited reviews of medically necessary drug products.

Bureau of Policy, Science and International Programs

The Bureau of Policy, Science and International Programs (BPSIP):

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

Bureau of Medical Sciences

The Bureau of Medical Sciences (BMS) 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). We also conduct urgent reviews for drugs under investigation by the Regulatory Operations and Regions Branch.

Our bureau also shares information about health issues and scientific advice with the public and health professionals and develops strategies for safe use of therapeutic products.

Medical Devices Bureau

The Medical Devices Bureau (MDB) reviews applications for:

  • new and amended medical device licences
  • applications for the sale of medical devices for use in investigational testing

We provide expedited access to unlicensed medical devices under the Special Access Programme for medical devices for emergency situations or when conventional therapies have failed, aren't suitable, or are not available. Our bureau also contributes to the policy and development of new medical device regulations and helps to clarify current regulations in collaboration with Policy, Planning and International Affairs Directorate..

Office of Planning, Performance and Review Services

The Office of Planning, Performance and Review Services (OPPRS) provides corporate support for the directorate. We deliver project management services and logistical support for the review of scientific pharmaceutical submissions. This includes the development of training, standard operating procedures, and documents supporting pre-market transparency.

We also:

  • hold regular meetings with stakeholders
  • provide strategic integrated planning, performance measurement, and quality auditing services
  • manage contracts with scientists from outside of the directorate
  • manage finances and funding in the directorate

Office of Clinical Trials

The Office of Clinical Trials (OCT) provides clinical and quality (chemistry and manufacturing) reviews of Clinical Trials 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 Programme requests for access to non-marketed drugs to treat medical emergencies when conventional therapies have failed, aren't suitable, or are not available.

Office of Risk Management

The Office of Risk Management (ORM) works with related offices outside of the directorate on:

  • compliance and enforcement of regulations
  • post-marketing issues (issues that come up after a product is allowed to be sold)
  • emergency preparedness and Business Continuity Planning

We provide urgent reviews for drugs under investigation by the Regulatory Operations and Regions Branch and help deal with drug shortages. We also manage the Drugs List for the Urgent Public Health Need regulatory pathway.

Office of Submission of Intellectual Property

The Office of Submission of Intellectual Property (OSIP) provides support to various directorates within the branch. We intake and process:

  • drug submissions and drug master files
  • drug identification number (DIN) issuance
  • cost recovery
  • information dissemination
  • database management
  • statistics reporting
  • web publication
  • records management

We are also responsible for administering drug related intellectual property regimes such as the Patented Medicines (Notice of Compliance) Regulations under the Patent Act and Data protection provisions under the Food and Drug Regulations. We review and approve drug submissions filed under the administrative pathway for brand name and manufacturer name changes. Our office also liaises with Justice Canada for litigation matters about patents and data protection.

For more information

Contact us

Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 3106B
Ottawa, Ontario
K1A 0K9

E-mail: OSIP-BPPI@hc-sc.gc.ca
Telephone: 613-957-0368
Fax: 613-952-7719
Teletypewriter: 1-800-465-7735 (Service Canada)

Bureaus

Bureau of Cardiology, Allergy and Neurological Sciences

Bureau of Cardiology, Allergy and Neurological Sciences
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 3102C
Health Canada
Ottawa, Ontario
K1A 0K9

E-mail: bcans_enquiries@hc-sc.gc.ca
Telephone: 613-941-1499
Fax: 613-941-1668
Teletypewriter: 1-800-465-7735 (Service Canada)

Bureau of Gastroenterology Infection and Viral Diseases

Bureau of Gastroenterology Infection and Viral Diseases
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 0202B
Health Canada
Ottawa, Ontario
K1A 0K9

E-mail: bgivd_enquiries@hc-sc.gc.ca
Telephone: 613-941-2566
Fax: 613-941-1183
Teletypewriter: 1-800-465-7735 (Service Canada)

Bureau of Metabolism, Oncology and Reproductive Science

Bureau of Metabolism, Oncology and Reproductive Science
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 0202D2
Health Canada
Ottawa, Ontario
K1A 0K9

E-mail: bmors_enquiries@hc-sc.gc.ca
Telephone: 613-941-3171
Fax: 613-941-1365
Teletypewriter: 1-800-465-7735 (Service Canada)

Bureau of Pharmaceutical Sciences (BPS)

Bureau of Pharmaceutical Sciences (BPS)
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 0201D
Health Canada
Ottawa, Ontario
K1A 0K9

E-mail: bps_enquiries_enquetes_bsp@hc-sc.gc.ca
Telephone: 613-941-3184
Fax: 613-957-3989
Teletypewriter: 1-800-465-7735 (Service Canada)

Bureau of Policy, Science and International Programs

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 3102C1
Health Canada
Ottawa, Ontario
K1A 0K9

E-mail: policy_bureau_enquiries@hc-sc.gc.ca
Telephone: 613-948-4623
Fax:: 613-941-1812
Teletypewriter: 1-800-465-7735 (Service Canada)

Medical Devices Bureau

Medical Devices Bureau
11 Holland Avenue, Tower A
2nd Floor
Address Locator: 3002A
Ottawa, Ontario
K1A 0K9

General inquiries

E-mail: mdb_enquiries@hc-sc.gc.ca
Telephone: 613-957-4786
Fax: 613-957-6345
Teletypewriter: 1-800-465-7735 (Service Canada)

Medical Devices Premarket review & Medical Devices Standards

Device Evaluation Division

Telephone: 613-954-0297

Information regarding device recalls

Health Product Inspectorate
Telephone: 1-800-267-9675

Special Access Program for medical devices

Telephone: 613-946-8711.
E-mail: sap_devices_mdb@hc-sc.gc.ca
Fax: 613-957-1596

ISO 13485 Quality System requirements

E-mail: iso13485_cmdcas_scecim@hc-sc.gc.ca
Telephone: 613-957-4786
Fax: 613-957-6345

Offices

Office of Planning, Performance and Review Services (OPPRS)

Office of Planning, Performance and Review Services (OPPRS)
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 3106C
Health Canada
Ottawa, Ontario
K1A 0K9

E-mail: opprs_enquiries@hc-sc.gc.ca
Telephone: 613-941-1248
Fax: 613-957-1483
Teletypewriter: 1-800-465-7735 (Service Canada)

Good Review Practices

Good Review Practices
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 3106B
Health Canada
Ottawa, Ontario
K1A 0K9

E-mail: grp_bpe@hc-sc.gc.ca
Telephone: 613-957-6448
Fax: 613-957-1483
Teletypewriter: 1-800-465-7735 (Service Canada)

Office of Clinical Trials (OCT)

Drug Clinical Trials

Office of Clinical Trials (OCT)
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 3105A
Health Canada
Ottawa, Ontario
K1A 0K9

E-mail: oct_bec_enquiries_enquetes@hc-sc.gc.ca
Fax: 613-946-7996
Teletypewriter: 1-800-465-7735 (Service Canada)

Office of Submissions and Intellectual Property

General inquiries

Office of Submissions and Intellectual Property
Health Products and Food Branch
Therapeutic Products Directorate
Address Locator: 0201A1
Health Canada
Ottawa, Ontario
K1A 0K9

E-mail: osip-bppi@hc-sc.gc.ca
Telephone: 613941-7281
Fax: 613-946-5610 613-941-0825
Teletypewriter: 1-800-465-7735 (Service Canada)

Cost Recovery

E-mail: osip-costrecovery-bppi-recouvcout@hc-sc.gc.ca
Telephone: 613-941-7283
Fax: 613-941-0285

Drug Master Files

E-mail: dmf-fmm@hc-sc.gc.ca
Telephone: 613-957-6813
Fax: 613-957-3989

eReview

E-mail: ereview@hc-sc.gc.ca
Fax: 613-957-4140

Office of Patented Medicines and Liaison

E-mail: opml_bmbl@hc-sc.gc.ca
Telephone: 613-941-7281
Fax: 613-946-5610

Office of Risk Management

Office of Risk Management
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 0700E
Health Canada
Ottawa, Ontario
K1A 0K9

E-mail: orm_bgr_enquiries_enquetes@hc-sc.gc.ca
Telephone: 613-954-6493
Fax: 613-954-4474
Teletypewriter: 1-800-465-7735 (Service Canada)

Regulatory Affairs

Regulatory Affairs
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 3000A
Health Canada
Ottawa, Ontario
K1A 0K9

E-mail: regaff-affreg@hc-sc.gc.ca
Telephone: 613-948-4623
Fax: 613-941-6458
Teletypewriter: 1-800-465-7735 (Service Canada)

Regulatory Project Management Division

Regulatory Project Management Division
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 0202D
Health Canada
Ottawa, Ontario
K1A 0K9

E-mail: rpm_division-gpr_division@hc-sc.gc.ca
Telephone: 613-954-6481
Fax: 613-941-6955
Teletypewriter: 1-800-465-7735 (Service Canada)

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: