Provision of Information regarding Post-marketing Safety

Information related to drugs, medical devices, regenerative medical products, and in vitro diagnostic products, PMDA medical safety information and information regarding newly introduced electronic package inserts are posted.

  <Examples>

• Individual Products (Information is available only in Japanese.)

　―　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 related events that have been repeatedly reported and cases leading to notifications for revisions of package inserts is described on 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 in an electronic way. This page introduces how the electronic package inserts are browsed, and its detailed systems and specifications.

Necessary Information in a Timely Manner

On this website, 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 reports of adverse drug reactions and adverse events reported by companies or medical professionals since April 2004, when PMDA was established, are also published sequentially. For the information related to adverse drug reactions and adverse events, PMDA provides information for not only healthcare professionals but also for general consumers such as “drug guides for patients,” which describe what you should know about prescription drugs that have “Warnings” in an easy-to-understand manner. Also, regarding the important safety information posted on the PMDA website, PMDA provides the “PMDA medi-navi,” a Pharmaceuticals and Medical Devices Information E-mail Alert Service.
Note: The information listed in this section is available only in Japanese.