Submitting risk management plans draft guidance document: Introduction

Health Canada has adopted and integrated the use of risk management plans (RMPs) and the International Conference on Harmonization (ICH) E2E Guideline into the regulatory review of drugs in Canada. A risk management plan (RMP) is a document that identifies and characterizes risks and uncertainties of a drug product.

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Title (French) Ébauche ligne directrice : Présentation des plans de gestion des risques : Introduction
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Open Canada Date Published 2023-01-18 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["plans de gestion des risques", "RMP", "soumission du RMP", "International Conference on Harmonisation", "ICH", "ICH E2E Guideline", "risques", "incertitudes des produits médicamenteux"], "en": ["risk management plans", "RMP", "submitting RMP", "International Conference on Harmonization", "ICH", "ICH E2E Guideline", "risks", "uncertainties of drug-products"]}
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