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Found 10 records similar to Good manufacturing practices guide for drug products (GUI-0001) - Summary
Drugs intended for use in clinical trials in Canada are regulated under Division 5 of Part C of the Food and Drug Regulations. Section C.05.010(j) requires the sponsor to ensure that drugs for use in clinical trials are manufactured, handled and stored in accordance with the applicable Good Manufacturing Practices requirements referred to in Divisions 2 to 4, except for Sections C.02.019, C.02.025 and C.02.026. Sponsors of clinical trials shall ensure that imported drugs are fabricated and packaged/labelled in accordance with these requirements.
This document will provide guidance to federally regulated holders of a licence under the Cannabis Act on how to meet the requirements of Part 5: Good Production Practices (GPP) of the Cannabis Regulations.
This guidance document pertains to Part 3 of the Natural Health Product Regulations (the Regulations) and is intended for manufacturers, packagers, labellers, importers, and distributors of natural health products (NHPs) for sale in Canada.
This document clarifies the requirements to be met for the issuance of a Certificate of a Pharmaceutical Product (CPP) or a certificate of Good Manufacturing Practices (GMP) and describes the procedure for their request.
Health Canada’s Veterinary Drugs Directorate (VDD) is clarifying the expectations for the information about Good Manufacturing Practices (GMP) status that should accompany veterinary drug submissions.
Evidence of Good Manufacturing Practices (GMP) for drug submissions. The goal of this revision is to better align the drug submission screening and review process with the Drug Establishment Licence (DEL) process. This should allow sponsors to make timely drug submissions while still providing adequate assurance of an establishment’s commitment to quality.
Companies must hold a site licence to manufacture, package, label or import natural health products (NHPs) in Canada. When doing these activities, companies must follow good manufacturing practices requirements (NHP GMPs) in the Natural Health Product Regulations (NHPR). It is a company’s responsibility to comply with the applicable regulatory requirements. When we identify an issue, we take compliance and enforcement actions based on several factors such as the risk to your health.
This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in humans to understand and comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations).
Division 1A of Part C of the Regulations applies to COVID-19 drugs. A person must hold a drug establishment licence (DEL) authorizing any activities conducted with respect to COVID-19 drugs.
Links to Health Canada guidance documents related to Good Clinical Practices