Safety Information regarding Drugs

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. The RMP is a document which shows the consistent risk management of drug from the development phase to the post-marketing phase. The RMP aims that the risks of drugs are evaluated at regular intervals or in response to the progress of post-marketing surveillance and a set of pharmacovigilance activities to minimize the risks of drugs. Sharing the published information among medical professionals is meant to ensure further enhancements of post-marketing safety measures.

The Yellow Letter / Blue Letter

This webpage contains Dear Healthcare Professional Letters of Emergent Safety Communications (the Yellow Letter) and Rapid Safety Communications (the Blue Letter). The Yellow Letter provides emergent and important safety information about drugs and medical devices. The Blue Letter provides information that does not require emergent communications but should be promptly provided to alert healthcare professionals.

Safety Information announced by MHLW

This section includes safety information (e.g. press release) announced by MHLW regarding pharmaceuticals and medical devices.

PMDA Risk Communications
(Drug Risk Information of ongoing evaluation)

This webpage contains the most recent Risk Communications from PMDA including early communications or ongoing safety review. The webpage intends to provide the public with easy access to important drug safety information.

Revisions of PRECAUTIONS

This webpage contains summary of evaluation results and detailed information on safety revisions of PRECAUTIONS in package inserts.
For "Standard Workflow for the Revision of Drug Product Package Inserts", please refer to Regulatory Information Page.

MHLW Pharmaceuticals and Medical Devices Safety Information (PMDSI)

This Pharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information collected by the Ministry of Health, Labour and Welfare. It is intended to facilitate safer use of pharmaceuticals and medical devices by healthcare professionals.

PMDA Alert for Proper Use of Drugs

"PMDA Alert for Proper Use of Drugs" provides the information on the proper use of pharmaceutical products which already has been alerted in package inserts or in other ways, however on which cases which were applied as relief benefits or were reported as adverse reactions have been still repeated. This page is intended to make easy-to-understand explanations using graphic illustrations on such safety matters that medical professionals should pay attention to and to ask them to maintain the proper use of drugs thoroughly.

Notifications Related to Safety Measures

Notifications issued from the Ministry of Health, Welfare and Labour (MHLW) related to safety measures for drugs are listed here.

English Translated Package Inserts

This webpage contains English translated Package Inserts prepared by Marketing Authorization Holders (MAHs).