Guidance on the Food and Drug Regulations for public health emergency drugs: References, key contacts
On this page
References
Authorization applications
- Management of drug submissions and applications
- Guidance document: Preparation of regulatory activities in the eCTD format
- Regulatory enrolment process
- Common electronic submissions gateway
- Management of regulatory submissions for veterinary drugs
- Filing submissions electronically
General
- Information and submission requirements for biosimilar biologic drugs
- Drug submissions relying on third-party data (literature and market experience)
- The use of foreign reviews by Health Canada
- Determining prescription status for human and veterinary drugs
- The Prescription drug list
- Regulatory requirements for drug identification numbers (DINs)
- Compliance and enforcement policy for health products (POL-0001)
- Drug and medical device databases
- Regulatory roadmap for biologic (Schedule D) drugs in Canada
- Draft guidance document: Disaggregated data requirements for human drugs (NEW)
- Guidance Document: Patented Medicines (Notice of Compliance) Regulations
- Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations
Safety and efficacy
- Non-clinical laboratory study data supporting drug product applications and submissions: Adherence to good laboratory practice
- Preparation of comparative bioavailability information for drug submissions in the CTD format
- Cochrane Handbook for Systematic Reviews of Interventions
- Preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement
Quality
- Guidance for industry on the preparation of the quality information for drug submissions in the CTD format: Biotherapeutic and blood products
- Preparation of quality information for drug submissions in the CTD format: Conventional biotherapeutic products
- Quality (chemistry and manufacturing) guidance: New drug submissions (NDSs) and abbreviated new drug submissions (ANDSs)
Labelling
- Review of drug brand names: Guidance document for industry
- Frequently asked questions review of drug brand names
- Good label and package practices guide for prescription drugs (GLPPG)
- Questions and answers: Plain language labelling regulations for prescription drugs
- Labelling of special containers policy
- Labelling of pharmaceutical drugs for human use
- Guidance on veterinary drug labelling
- Product monograph guidance documents and notices
COVID-19 drugs
COVID-19 vaccines
- Guidance for market authorization requirements for COVID-19 vaccines: Requirements for vaccines to address SARS-CoV-2 variants
- ACCESS Consortium: Points to consider for strain changes in authorized COVID-19 vaccines in an ongoing SARS-CoV2 pandemic
Establishment licensing
- Guidance on drug establishment licences and drug establishment licensing fees (GUI-0002)
- Management of applications and performance for drug establishment licences (GUI-0127)
Good manufacturing practices
- Good manufacturing practices guide for drug products (GUI-0001)
- Annex 2 to the current edition of the good manufacturing practices guidelines schedule D drugs (biological drugs) (GUI-0027)
- How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)
- Good manufacturing practices (GMP) for active pharmaceutical ingredients (APIs) (GUI-0104)
Good laboratory practices
Post-market vigilance
- Reporting adverse reactions to marketed health products (overview)
- Report an adverse reaction to a drug: industry
- Preparing and submitting summary reports for marketed drugs and natural health products
- Good pharmacovigilance practices (GVP) guidelines (GUI-0102)
- Notifying Health Canada of foreign actions: Guidance document for industry
- Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)
- Format and content for post-market drug benefit-risk assessment in Canada
- Submission of risk management plans and follow-up commitments
- Guide to reporting drug shortages and discontinuations
- Recall policy for health products (POL-0016)
- Drug and natural health products recall guide (GUI-0039)
Post-notice of compliance (NOC) changes
- Post-notice of compliance (NOC) changes: Framework document (pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
- Quality document
- Safety and efficacy document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)Framework document for veterinary drugs
- Guidance for safety and efficacy of veterinary drugs
- Guidance for quality of veterinary drugs
- Guidance on veterinary drug labelling
Advertising webpages
Disinfectants guidance documents and monograph
- Management of disinfectant drug applications
- Safety and efficacy requirements for surface disinfectant drugs
- Disinfectant drugs
- Applying for a drug identification number (DIN) for a disinfectant drug during the COVID-19 pandemic
- Hard-surface disinfectants monograph
Non-prescription pharmaceuticals and hand sanitizer (antiseptic skin cleansers)
Key contacts
To help ensure that we prioritize your inquiry, include "public health emergency drug" in the subject line of your email.
Biologic and Radiopharmaceutical Drugs Directorate
Office of Regulatory Affairs
Email: brdd.ora@hc-sc.gc.ca
Pharmaceutical Drugs Directorate
Regulatory Project Management Division
Email: rpmd-dgpr@hc-sc.gc.ca
Marketed Health Products Directorate
Regulatory Project Management Office
Email: bbrs.rpm-gpr.bbra@hc-sc.gc.ca (Biologics, Radiopharmaceuticals, and Self-Care Products)
Email: mpb.rpm-gpr.bppc@hc-sc.gc.ca (Marketed Pharmaceutical Products)
Veterinary Drugs Directorate
Submission and Knowledge Management Division
Email: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca
Natural and Non-prescription Health Products Directorate
Email: nnhpd-dpsnso@hc-sc.gc.ca
Application format-related inquiries
Business Facilitation and Modernization Directorate
Email: ereview@hc-sc.gc.ca
Adverse reaction reporting-related inquiries:
Canada Vigilance Program (CVP)
Inquiries about good manufacturing practices compliance requirements
Email: GMP_Questions_BPF@hc-sc.gc.ca