Publication

M-21: Guideline for Postmarketing Quality and Safety (Pharmacovigilance) Requirements in North America

Abstract

This publication provides guidance for postmarketing quality and safety reporting (pharmacovigilance) to U.S. Food and Drug Administration (FDA) and Health Canada (HC). This guidance is intended to aid U.S. and Canadian companies that market common medical gases (i.e., oxygen, nitrogen, medical air, carbon dioxide, nitrous oxide, helium, and carbon monoxide and medically appropriate mixtures thereof) in setting up a pharmacovigilance reporting system that satisfies local and regional regulatory requirements, bearing in mind any global requirements when applicable. Common medical gases in the United States are referred to as designated medical gases or medically appropriate mixtures thereof.

This publication does not address reporting requirements for gases or medical gas equipment classified as medical devices (materiovigilance). Nor does it address reporting requirements for medical gases approved under 21 CFR Part 314.

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Properties

Edition:
3
Published:
December 2025
Status:
Available To the Public
Size:
8 pages
Publisher:
CGA
Special Attributes:
Notes:
Committee:
Medical Gases

Cataloging

Category
Medical Gases     Standards & Guidelines
Keywords
medical gases  |  Pharmacovigilance
Related
(none)