Submitting risk management plans draft guidance document: Introduction (English, HTML)

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Publisher-reported update

2024-04-04

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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