Description

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.

Resources

Name	Format	Description	Link
Submitting risk management plans draft guidance document: Introduction	HTML		https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/submitting-risk-management-plans.html
Submitting risk management plans draft guidance document: Introduction	HTML		https://www.canada.ca/fr/sante-canada/programmes/consultation-projet-reglementation-souple-lignes-directrices-homologation-medicaments-instruments-medicaux/presentation-plans-gestion-risques.html

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