Guidance on procedures and administrative requirements for master files: References
On this page
- Health Canada documents
- International Council on Harmonisation Guidelines
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) documents
Health Canada documents
Legislation
- Food and Drugs Act
- Food and Drug Regulations
- Medical Devices Regulations
- Access to Information Act
- Library and Archives of Canada Act
Related guidance documents
- Master File application form
- Guidance for industry: The management of drug submissions and applications
- Guidance document on post-drug identification number (DIN) changes
- Guidance document: Preparation of drug regulatory activities in the non-eCTD format
- Guidance document: Preparation of regulatory activities in the electronic common technical document (eCTD) format (available upon request from the “Filing submissions electronically” page)
- Guidance for industry: Preparation of veterinary new drug submissions
- Guidance document - Quality (chemistry and manufacturing) guidance: New drug submissions (NDSs) and abbreviated new drug submissions (ANDSs)
- Evidence for quality of finished natural health products
- Post-notice of compliance (NOC) changes: Quality document
- Notice: Guidance for industry: Pharmaceutical quality of aqueous solutions
- Guidance for industry: Pharmaceutical quality of inhalation and nasal products
- Guidance document: Quality (chemistry and manufacturing) guidance: Clinical trial applications (CTAs) for pharmaceuticals
- Guidance document for clinical trial sponsors: Clinical trial applications
- Guidance for industry: Stereochemical issues in chiral drug development
- Guidance for Industry: Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotherapeutic and Blood Products
- Guidance document: Harmonized requirements for the licensing of vaccines and guidelines for the preparation of an application
- Guidance document: Submission and information requirements for extraordinary use new drugs (EUNDs)
- Good manufacturing practices guide for drug products (GUI-001)
- Summary of Annex 3B to the Good manufacturing practices guide: Positron-emitting radiopharmaceuticals
- Cleaning validation guide (GUI-0028): Summary
- Guide to validation: Drugs and supporting activities (GUI-0029)
- Guidance document: Preparation of clinical trial applications for use of cell therapy products in humans
- Guidance document: Plant molecular farming (PMF) applications: Plant-derived biologic drugs for human use