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The Yellow Letter / Blue Letter

To prevent health hazards associated with the use of drugs and medical devices, it is important that post-marketing reports of adverse reactions and defects be collected and reviewed in order to promptly provide feedback about necessary information to medical institutions.

According to Article 77-4 of the Pharmaceutical Affairs Law (Law No. 145, 1960), when MAHs of drugs or medical devices learn that the use of drugs or medical devices that they have marketed might cause 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 contains emergent and important safety information about drugs and medical devices. The Blue Letter contains information that does not require emergent communications as Yellow Letter but should be promptly provided to alert healthcare professionals.

 

JCN 3010005007409

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

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The Yellow Letter / Blue Letter
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