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:

• clinical trials of biologics and radiopharmaceuticals
• biologic drugs for human use
• radiopharmaceutical drugs for human use

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

• screens and validates submissions and applications
• coordinates and facilitates meetings with sponsors
• provides regulatory and policy guidance to sponsors
• receives and issues all regulatory correspondence for BRDD

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, 6^th 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:

• Division of Reproduction and Urology Drugs
• Division for Oncology Drugs
• Division of Metabolic and Musculoskeletal Drugs

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

• diabetes
• menopause
• haematology
• osteoporosis
• contraception
• erectile dysfunction
• hormone replacement
• musculoskeletal anti-inflammatories
• oncology (includes hormone-based therapies)

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

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

• Division of Anti-Infective Drugs
• Division of AIDS and Viral Diseases Drugs
• Division of Gastroenterology, Imaging, Ophthalmology, and Dermatology

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

• sterile diluents
• contrast agents
• ophthalmic drugs
• parenteral nutrition products
• antidotes and poison treatments
• immunosuppressant drugs for transplants and skin disorders
• drugs to treat gastrointestinal disorders, conditions, and diseases
• drugs to treat dermatological disorders, conditions and diseases limited to the skin
• antimicrobial drugs (antibacterials/antibiotics, antivirals, antifungals, antiparasitics)

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

• brand name assessments
• product monographs for subsequent entry products
• inner and outer package labels and package inserts
• patient and consumer information on product monographs
  • explains what the medication is for, how to use it and the potential side effect

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:

• bgivd_enquiries@hc-sc.gc.ca (all enquiries except to the ASU and LD)
• pdd.bgivd.asu-dmp.bgmiv.usa@hc-sc.gc.ca (ASU enquiries)
• pdd.bgivd.ld-dmp.bgmiv.de@hc-sc.gc.ca (LD enquiries)

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:

• review first-in-class submissions
• review submissions relying on third-party data, especially when the Canadian medical practice context is required
• determine priority review submission status
• assess requests for advance consideration of a notice of compliance with conditions
• conduct medical necessity determinations for the PDD
• conduct health risk assessments

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:

• bmsenquiriesenquetesbsm@hc-sc.gc.ca (general enquiries)
• bmsrisk-bsmrisque@hc-sc.gc.ca (BMS-RMD Risk Management Division)

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

• Division for Cardio-Renal Drugs
• Division of Allergy and Respiratory Drugs
• Division for Central Nervous System Drugs

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

• stroke
• obesity
• dialysis
• neurology
• psychiatry
• vasodilators
• hypertension
• diuretic drugs
• anesthesiology
• antiplatelet drugs
• pain management
• plasma expanders
• myocardial ischemia
• antithrombotic drugs
• substance-related disorders
• immunosuppressant drugs for allergies, asthma, coughs and colds

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, 5^th Floor
Address locator: 3105A
Ottawa ON  K1A 0K9

Email:

• oct.enquiries-requetes.bec@hc-sc.gc.ca (general enquiries)
• oct.pre.cta-dec.bec@hc-sc.gc.ca (pre-CTA meeting requests)

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:

• communicate progress internally and externally
• coordinate review streams as well as pre-submission meetings
• ensure that policies, guidelines, processes and practices are applied consistently across the division

They also:

• ensure that sponsors of submissions and applications have met the minimum requirements
• monitor adherence to review performance standards

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:

• assesses the potential benefits and risks of a medical device
• reviews applications for investigational testing authorizations for medical devices to ensure that studies are well designed and participants will not be exposed to undue risk

The Bureau of Licensing Services within MDD:

• authorizes the sale of lower-risk Class II medical devices
• provides project management services and logistical support for medical device licence applications
• responds to enquiries from stakeholders on the classification of their medical device

Medical Devices Directorate
Health Products and Food Branch
Health Canada
11 Holland Ave, Tower A, 2^nd 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:

• manages the issuance of dossier IDs for eCTD and non-eCTD pharmaceutical, biological, master file and clinical trial submissions
• receives and evaluation samples in eCTD format
• manages the Electronic Submission Gateway (ESG)

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 , 7^th 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:

• monitors and collects adverse reaction and medication incident data for drugs and medical devices
• reviews and analyzes marketed health product safety data
• conducts risk-benefit assessments of marketed health products
• communicates risks about a product to health professionals and the public

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:

• bbrs.rpm-gpr.bbra@hc-sc.gc.ca (biologics and radiopharmaceuticals)
• mpb.rpm-gpr.bppc@hc-sc.gc.ca (pharmaceuticals)

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

• maintains databases such as the Drug Submission Tracking System, the Drug Products Database and the Notice of Compliance Database
• administers the Fees in Respect of Drugs and Medical Devices Regulations
• assigns drug identification numbers (DINs)
• applies regulatory requirements for DINs

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

• Patented Medicines (Notice of Compliance) Regulations
• data protection provisions under section C.08.004.1 of the Food and Drug Regulations
• Certificates of Supplementary Protection under the Patent Act

Office of Submissions and Intellectual Property
Jeanne Mance Building
200 Eglantine Driveway, 8^th 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