Pmda - Pharmaceuticals and Medical Devices Agency

Post-marketing Safety Measures

The Yellow Letter / Blue Letter

To prevent health hazards associated with the use of drugs, it is important that post-marketing reports of adverse drug reactions be collected and reviewed in order to promptly provide feedback about necessary information to medical institutions.
Under Article 68-10, Paragraph 1 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960), when the marketing authorization holders of drugs learn that the use of drugs that they have marketed might cause the onset or spread of hazards to public health or hygiene, necessary measures shall be taken, including recall, suspension of sales, and information provision to prevent such hazards.
Based on the above provision, various types of safety information have been provided. Particularly important safety information which requires immediate communication is provided through the Dear Healthcare Professional Letters of Emergent Safety Communications (Yellow Letter) or Dear Healthcare Professional Letters of 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.