Pmda - Pharmaceuticals and Medical Devices Agency

Post-marketing Safety Measures

Provision of Information Regarding Post-marketing Safety

Information related to drugs, medical devices, regenerative medical products, and in vitro diagnostics, PMDA medical safety information, and information regarding newly introduced electronic package inserts are shown on these pages.

Drugs   Medical Devices
Regenerative Medical Products   In-vitro Diagnostics
 Information regarding drugs
  • Individual products (English information is available only for RMP.)

 ― Package Inserts,  Risk Management Plan (RMP),  Drug Guide for Patients

  • Alerts

 ― Dear Healthcare Professional Letters of Emergent Safety Communications (Yellow Letter) , Dear Healthcare Professional Letters of Rapid Safety Communications (Blue Letter),  Revisions of PRECAUTIONS,  Notification Related to Safety Measures, etc.

  • Adverse drug reaction (ADRs), etc. (only in Japanese)

 ― Manuals for Management of Individual Serious Adverse Drug Reactions (for patients and general consumers, for healthcare professionals) ,  Cases With Suspected ADRs Reports, etc.

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 issuance of notifications on revisions of PRECAUTIONS is described in the "PMDA Medical Safety Information" in an easy-to-understand manner and is widely disseminated.

Information Regarding Newly Introduced Electronic Package Inserts

Following the amendment of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Pharmaceuticals and Medical Devices Act), paper-based package inserts that used to be enclosed with products are abolished in principle from August 2021*. Basically, package inserts should be browsed electronically. This page introduces how the electronic package inserts are browsed, and their detailed systems and specifications.

Necessary Information in a Timely Manner

On this website, the PMDA provides a wide range of information on the quality, efficacy, and safety of drugs, medical devices, and regenerative medical products including information on package inserts, RMP, recall information, and emergent safety communications.

All cases of adverse reactions and malfunctions reported by companies or healthcare professionals since April 2004, when the PMDA was established, are also published sequentially. For the information related to drugs or adverse drug reactions, the PMDA provides information not only for healthcare professionals but also for general consumers, such as “drug guides for patients,” which describe what general consumers should know about prescription drugs with a “Warnings” section in package inserts in an easy-to-understand manner. Also, regarding the important safety information posted on the PMDA website, the PMDA provides the “PMDA medi-navi,” a Pharmaceuticals and Medical Devices Information E-mail Alert Service. (These services are available only in Japanese.)