The PMDA provides the following safety information regarding drugs.
RMP: Risk Management Plan
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 the risks of drugs to be evaluated at regular intervals or in response to the progress of post-marketing surveillance and pharmacovigilance activities to minimize the risks of drugs. It is expected that further enhancements of post-marketing safety measures are ensured by publishing RMP and sharing the information on risk management among healthcare professionals.
Yellow Letter/Blue Letter
This webpage contains Dear Healthcare Professional Letters of Emergent Safety Communications (Yellow Letter) and Rapid Safety Communications (Blue Letter). The Yellow Letter provides emergent and important safety information about drugs. The Blue Letter provides information that does not require emergent communications compared to the Yellow Letter but should be promptly provided to alert healthcare professionals.
Safety Information Announced by the MHLW
This section includes safety information (e.g., press release) announced by the MHLW regarding drugs.
PMDA Risk Communications
(Drug risk information of ongoing evaluation)
This webpage contains the most recent risk communications from the PMDA including early communications or the ongoing safety reviews. The webpage aims to provide the public with easy access to important drug safety information.
Revisions of PRECAUTIONS
This webpage contains a summary of evaluation results and detailed information on revisions of PRECAUTIONS in package inserts.
For "Standard Workflow for Consideration of Safety Measures Such as Revision of Electronic Drug Product Package Inserts," please refer to Notifications Related to Safety Measures (Drugs).
MHLW Pharmaceuticals and Medical Devices Safety Information (PMDSI)
Pharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information collected by the MHLW. It is intended to facilitate safer use of drugs and medical devices by healthcare professionals.
PMDA Alert for Proper Use of Drugs
PMDA Alert for Proper Use of Drugs provides information on the proper use of pharmaceutical products for which patients applied for relief benefits or cases of adverse reactions were reported repeatedly, in spite of the fact that precautions for those drugs had been already issued in package inserts or in other ways. This page is intended to make easy-to-understand explanations using graphic illustrations on such safety matters to which healthcare professionals should pay attention, and it asks them to thoroughly continue the proper use of drugs.
Notifications Related to Safety Measures (drugs)
Notifications issued by the MHLW related to safety measures for drugs are listed here.
English-translated Package Inserts
This webpage contains English-translated package inserts prepared by the marketing authorization holders.