Submitting risk management plans draft guidance document: Introduction

Name: Submitting risk management plans draft guidance document: Introduction
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

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.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2024-04-04

Data overview

Formats: HTML
File languages: English, French

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Government of Canada Open Data
Open Government Licence – Canada

Resources

Submitting risk management plans draft guidance document: Introduction (English, HTML) HTML
Submitting risk management plans draft guidance document: Introduction (French, HTML) HTML

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Health Canada