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POL-0030: Compliance and enforcement approach and inspection strategy for clinical trials of drugs involving human subjects Download the alternative format (PDF format, 1,393 Kb, 25 pages) Organization: Health Canada Date published: November 30, 2021 Date issued: 30 November 2021…

Part C, Division 5 of the Food and Drug Regulations "Drugs for Clinical Trials Involving Human Subjects" (GUI-0100): Overview Overview Application and authorization Good clinical practices Labelling and records Submission of information and samples Serious unexpected adverse drug…

Good manufacturing practices inspection policy for drug establishments (POL-0011) (PDF Version - 1.1 MB) Contact Information Disclaimer This document does not constitute part of the Food and Drugs Act (the Act) or its regulations and in the event of any inconsistency or conflict…

ARCHIVED - Drug Identification Number (DIN) Enforcement Policy (POL-0040) We have archived this page and will not be updating it. You can use it for research or reference. We have archived this page and will not be updating it. You can use it for research or reference. (December…

Guidance Policy - Use of Positron Emitting Radiopharmaceuticals (PERs) in Basic Research Policy (POL-0053) (February 24, 2006) Contact Name: Drug GMP Inspection Unit Tel: 613-952-9319 Fax: 613-957-6709 E-Mail: GMP_Questions_BPF@hc-sc.gc.ca (PDF Version - 112 K) Health Products…

Guidance Documents, Directives and Policies The Health Products and Food Branch Inspectorate (Inspectorate) is responsible for all activities concerning compliance and enforcement of the Food and Drugs Act (FDA) (with the exception of products regulated as foods which are the…

Drug good manufacturing practices (GMP) and drug establishment licence (DEL) enforcement policy (POL-0004) Download in PDF format (1.36 MB, 17 pages) Organization: Health Canada or Public Health Agency of Canada Cat: H139-40/2022E-PDF ISBN: 978-0-660-42658-7 Pub: 210747…

Table A: Foreign Building Conducting Active Pharmaceutical Ingredient Related Licensable Activities Table A is used to list all foreign buildings conducting licensable activities with regards to Active Pharmaceutical Ingredients imported into Canada and/or for all Active…

Drug establishment licence application: form and instructions (FRM-0033) Drug establishment licence application form Table of Contents When to use this form Instructions Table 1: Drug Establishment Licence (DEL) information (existing DEL holders Only) Table 2: Application type…

Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices (GUI-0049) Introduction This standard is considered a voluntary standard and applies to fabricators, packagers/labellers, distributors,…