Guidance on management of drug submissions and applications: References
Health Canada has published numerous guidelines, policies and reference documents to help sponsors prepare and file drug submissions and applications. The following list of guidance documents and policies is not exhaustive. These documents should be read along with this guidance document.
General filing
- Filing submissions electronically
- Management of disinfectant drug applications
- Questions and answers - Prescription Drug List
- Regulatory requirements for drug identification numbers (DIN)
- Guidance on switching from prescription to non-prescription status
- Guidance document: Patented Medicines (Notice of Compliance) Regulations
- Guidance document: Classification of products at the cosmetic-drug interface
- Guidance document: Data protection C.08.004.1 of the Food and Drug Regulations
- Fees for the review of human drugs and disinfectant submissions and applications
- Reconsideration of decisions sent for human drug and natural health products submissions
- Administrative processing of submissions and applications: Human or disinfectant drugs
- Preparation of drug regulatory activities in electronic common technical document (eCTD) format
- Guidance Document: The Regulatory Enrolment Process (REP): Drugs for Human/ Veterinary Use and Disinfectants
- Development safety update report (DSUR) - International Conference on Harmonisation (ICH) Topic E2F
Other filing processes
- Guidance for industry - Priority review of drug submissions
- Guidance document: Notice of compliance with conditions (NOC/c)
- Guidance on the Food and Drug Regulations for public health emergency drugs (PHED)
- Guidance document: Drug submissions relying on third party data (literature and market experience)
- Guidance document - Submission and information requirements for extraordinary use new drugs (EUNDS)
Labelling
- Non-prescription drugs: Category IV monographs
- Non-prescription drugs labelling standards - Drug product
- Guidance document for industry - Review of drug brand names
- Guidance document: Drug facts table for non-prescription drugs
- Guidance document: Electronic Canadian drug facts table (eCDFT) technical standards
- Guidance document: Questions and answers: Plain language labelling regulations for prescription drugs
- Guidance document: Questions and answers: Plain language labelling regulations for non-prescription drugs
Post-authorization changes
- Guidance document: Post-drug identification number (DIN) changes
- Guidance document: Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
- Guidance document: Post-notice of compliance (NOC) changes: Quality
- Guidance document: Post-notice of compliance (NOC) changes: Safety and efficacy (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
Clinical trials
- Guidance document for clinical trial sponsors: Clinical trial applications
- Guidance document: Quality (Chemistry and Manufacturing) Guidance: Clinical trial applications (CTAs) for pharmaceuticals
- Guidance document: Part C, Division 5 of the Food and Drug Regulations “drugs for clinical trials involving human subjects” (GUI-0100) - Summary
Medical devices and combination products
- Policy on drug/medical device combination products
- Policy on drug/medical device combination products - Decisions
- Guidance document: Management of applications for medical device licences
- Guidance document: Classification of products at the drug-medical device interface
- Classification of health products at the device-drug interface (questions and answers)
- Applications for medical device investigational testing authorizations guidance document - Summary
Biologics
- Guidance document: Blood Regulations
- Guidance document: Annual update of seasonal influenza vaccines
- Guidance for sponsors: Lot Release Program for Schedule D (biologic) drugs
- Guidance document: Information and submission requirements for biosimilar biologic drugs
- Lot release - Guidance documents - Applications and submissions - Biologics, radiopharmaceuticals and genetic therapies