Guidance on management of drug submissions and applications: Contact us

The following work areas review drug submissions and applications.

Biologic and Radiopharmaceutical Drugs Directorate (BRDD)

BRDD is the Canadian regulatory authority that regulates within the scope of this guidance document:

The Office of Regulatory Affairs within BRDD manages submissions and applications associated with the products that the directorate regulates. It:

Office of Regulatory Affairs
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture
100 Eglantine Driveway
Address locator: 0601C
Ottawa ON  K1A 0K9

Telephone: 613-957-1722
Email: brdd.ora@hc-sc.gc.ca

Learn more about the Biologic and Radiopharmaceutical Drugs Directorate.

Pharmaceutical Drugs Directorate (PDD)

PDD regulates human prescription pharmaceutical (for example, chemically synthesized) products.

Depending upon therapeutic class and the types of studies filed in support of a pharmaceutical submission, the safety and efficacy (clinical and pre-clinical) component may be reviewed by one or more of the four review Bureaus in the PDD, whose functions are described below. The quality (chemistry and manufacturing) component of all pharmaceutical submissions is reviewed by the Bureau of Pharmaceutical Sciences.

Director General's Office
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Tower B
1600 Scott Street, 6th Floor
Address locator: 3106B
Ottawa ON  K1A 0K9

Telephone: 613-957-0368
Teletypewriter: 1-800-465-7735 (Service Canada)
Email: pharma_drug_enquiries-renseignements_medicaments_pharma@hc-sc.gc.ca

The Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS) has 3 divisions:

Among its responsibilities, BMORS oversees the clinical, pre-clinical and labelling review of submissions of pharmaceutical drugs used for:

Email: bmors.enquiries@hc-sc.gc.ca

The Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD) has 3 divisions:

Among its responsibilities, BGIVD oversees the clinical, pre-clinical and labelling review of submissions for:

BGIVD also houses the Labelling Division (LD), which reviews labelling information that is distributed with a drug, such as:

The Administrative Submissions Unit (ASU) in the Labelling Division conducts the administrative screening of submissions and applications filed for changes to the manufacturer or brand name.

Email:

The Bureau of Medical Sciences (BMS) has medical evaluators assigned to 1 of 2 medical sciences divisions (set up like the review bureaus in PDD). Among their responsibilities, the evaluators:

BMS also provides a medical consultation service to the other review bureaus when requested. As such, medical evaluators attend pre-submission meetings across the review bureaus.

The Risk Management Division (RMD), which resides within BMS, coordinates health risk assessments, medical necessity determinations and drug shortages files. It also liaises with the Regulatory Operations and Enforcement Branch (ROEB).

Email:

The Bureau of Cardiology, Allergy and Neurological Sciences (BCANS) has 3 divisions:

Among its responsibilities, BCANS oversees the clinical, pre-clinical and labelling review of submissions used in or for:

Email: bcansenquiries@hc-sc.gc.ca

Bureau of Pharmaceutical Sciences (BPS) oversees the chemistry and manufacturing review as well as the scientific review of clinical comparative bioavailability studies. These studies include, for example, bioequivalence studies for all submission types of all therapeutic classes of pharmaceutical products. BPS also assesses pharmaceutical product information and labelling of generic product submissions.

Email: bpsenquiries@hc-sc.gc.ca

The Office of Clinical Trials (OCT) manages and evaluates information related to clinical trial applications for drug products used in phase 1, 2 or 3 clinical trials. Among its responsibilities, OCT receives and reviews clinical trial applications, including serious unexpected adverse drug reactions related to clinical trials. It also provides guidance to stakeholders.

Submission Management Division, Office of Clinical Trials
Pharmaceutical Drugs Directorate
Health Canada
Holland Cross, Tower B
1600 Scott Street, 5th Floor
Address locator: 3105A
Ottawa ON  K1A 0K9

Email:

The Regulatory Project Management Division (RPMD) resides in the Office of Planning, Performance and Review Services where regulatory project managers are assigned to each bureau.

The regulatory project managers are the key regulatory contacts for submissions and applications. They:

They also:

Email: rpmd-dgpr@hc-sc.gc.ca

Medical Devices Directorate (MDD)

MDD reviews scientific information to assess the safety, effectiveness and quality of medical devices. MDD also:

The Bureau of Licensing Services within MDD:

Medical Devices Directorate
Health Products and Food Branch
Health Canada
11 Holland Ave, Tower A, 2nd Floor
Address locator: 3002A
Ottawa ON  K1A 0K9

Telephone: 613-957-4786
Fax: 613-957-6345
Email: meddevices-instrumentsmed@hc-sc.gc.ca

Business Facilitation and Modernization Directorate (BFMD)

BFMD supports the Health Products and Food Branch. It provides direction, coordination, support on information technology and information management. It also ensures that governance mechanisms are in place to allow the branch to deliver effectively on legislated functions.

The Business Informatics and Information Science Division within BFMD:

Email: ereview@hc-sc.gc.ca

Natural and Non-prescription Health Products Directorate (NNHPD)

NNHPD oversees the regulation of non-prescription drugs, biocides, disinfectant drugs and natural health products. Among its responsibilities, the Non-Prescription Drug Evaluation Division within NNHPD manages the scientific review of pre-market applications and all issues related to non-prescription drugs, including DIN applications for products subject to Category IV monographs and labelling standards, as well as biocides and disinfectant products. (Responsibility for reviewing Division 8 generic drugs, such as ANDSs and SANDSs, lies with BPS.)

Regulatory Project Management Unit
Natural and Non-prescription Health Products Directorate
Health Canada
2 Constellation Drive , 7th Floor
Address Locator: 2607A
Ottawa ON  K1A 0K9

Email: nnhpd-dpsnso@hc-sc.gc.ca

Marketed Health Products Directorate (MHPD)

MHPD monitors and assesses the safety of authorized health products in Canada and takes regulatory action when safety issues are identified. MHPD uses a risk-based approach to make regulatory decisions, which are communicated in an open and transparent manner to help people in Canada make informed decisions. The directorate:

Regulatory Project Management Office
Bureau of Strategic Engagement and Integrated Management Services
Health Canada
Jeanne Mance Building
200 Eglantine Driveway
Address locator: 1912A
Ottawa ON  K1A 0K9

Email:

The Office of Submissions and Intellectual Property (OSIP) within MHPD processes submissions and applications, including invoicing of fees. It also:

The Office of Patented Medicines and Liaison within OSIP administers the:

Office of Submissions and Intellectual Property
Jeanne Mance Building
200 Eglantine Driveway, 8th Floor, Room 811A
Address locator: 1908A
Ottawa ON  K1A 0K9

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

Cost recovery (human drug submissions)
Fax: 613-941-0285
Email: cost.recovery@hc-sc.gc.ca

Drug Identification Number Unit
Email: din@hc-sc.gc.ca

Master File Administration Unit
Email: dmf.enquiries-fmm@hc-sc.gc.ca

How to file submissions and applications
Email: ereview@hc-sc.gc.ca

Office of Patented Medicines and Liaison
Email: opml-bmbl@hc-sc.gc.ca

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2025-10-01