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English-Translated Package Inserts | Pharmaceuticals and Medical . . . - PMDA Note) English-translated package insert is also available by clicking the link to "Package Insert (English) PDF ver " in the "Package insert information in Japanese" page Please note; These English translations are prepared by the MAHs The Japanese language package insert is the official document, and this translation is provided solely as a reference material In the case of any discrepancy
Risk Management Plan (RMP) - PMDA Summary of risk management plan (RMP) In order to ensure the safety of drugs, it is important to assess measures for appropriate management of the risks of drugs at any time from the development phase to the regulatory review and the post-marketing phase RMP is a document which shows the consistent risk management of drugs from the development phase to the post-marketing phase RMP aims for