Safty Information



Safety Information

PMDA provides the following safety information regarding pharmaceuticals and medical devices.

  • PMDA Risk Communications (Drug Risk Information of ongoing evaluation) Updated
  • 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.
  • The Yellow Letter / Blue Letter New
  • 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 Updated
  • This section includes safety information (e.g. press release) announced by MHLW regarding pharmaceuticals and medical devices.
    e.g <Q and A> Resuming vaccination with the pediatric pneumococcal conjugate vaccine and the Hib vaccine (dated March 29 2011)
  • 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 providers.
  • PMDA Medical Safety Information
  • Among the medical incident reports and adverse drug reaction/malfunction reports that have been collected to date, information on similar events that have been repeatedly reported and cases leading to notifications for revisions to package inserts are described on the “PMDA Medical Safety Information” site in an easily understandable manner and widely disseminated. Important reminders to encourage safe use of drugs and medical devices to healthcare professionals are included, which have been considered based on the opinions of healthcare professionals such as physicians, pharmacists, nurses, and clinical engineers, specialists such as those in the field of ergonomics, as well as industry organizations such as marketing approval holders of pharmaceuticals or medical devices.
  • PMDA Request for Proper Use of Drugs Updated
  • “PMDA Request 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.

Pharmaceuticals and Medical Devices Agency

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan


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