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Found 20921 records

On February 10, 2022, the Health Product Compliance Directorate posted Good manufacturing practices guidelines for active pharmaceutical ingredients - (GUI-0104). …

Last Updated: Feb 27, 2023
Date Published: Feb 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of publication GMP guidelines active pharmaceutical ingredients GUI-0104

This guide is for people who work with Active Pharmaceutical Ingredients (APIs) and their intermediates to understand and comply with …

Last Updated: Feb 27, 2023
Date Published: Feb 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: GMP guidelines active pharmaceutical ingredients GUI-0104

Health Canada is closely monitoring Russia's invasion of Ukraine for any potential impacts on the drug supply for Canada.

Last Updated: Feb 27, 2023
Date Published: Feb 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug quality drug supply chain requirements Russia's invasion-of Ukraine Russia's invasion potential-impacts

Health Canada has made changes to the policy on drug good manufacturing practices (GMP) and drug establishment licence (DEL) enforcement …

Last Updated: Feb 27, 2023
Date Published: Feb 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: good manufacturing practices drug GMP DEL enforcement POL-0004 changes to policy

In 2017, we did a proactive compliance monitoring project to check how 23 companies followed NHP GMPs.

Last Updated: Feb 27, 2023
Date Published: Feb 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: compliance monitoring project good manufacturing practices natural health products NHP GMPs

It is an annex to the latest version of the Good manufacturing practices guide for drug products (GUI-0001) and Good …

Last Updated: Feb 27, 2023
Date Published: Feb 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: good manufacturing practices GMP guide Annex 3B positron-emitting radiopharmaceuticals GMP guide drug products GUI-0001 GMP for active-pharmaceutical- ingredients API GUI-0104

Summary of the Mutual Recognition Agreement (MRA) Evaluation Guide

Last Updated: Feb 27, 2023
Date Published: Feb 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: mutual recognition agreement MRA evaluation guide GMP compliance programs

A drug shortage is when a drug manufacturer isn't able to supply enough of a drug to meet all of …

Last Updated: Feb 27, 2023
Date Published: Feb 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug drug orders drug shortages addressing drug shortages information for health-care-providers

A drug shortage is when a drug manufacturer isn't able to supply enough of a drug to meet all of …

Last Updated: Feb 27, 2023
Date Published: Feb 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug drug orders drug shortages addressing drug shortages Information for industry market authorization holders

Drug shortages are a complex, global problem involving all stakeholders across the drug supply chain. The Multi-Stakeholder Steering Committee on …

Last Updated: Feb 27, 2023
Date Published: Feb 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug drug orders drug shortages addressing drug shortages complex-global problem stakeholders drug supply chain Multi-Stakeholder Steering Committee