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Japan: Partial amendment to the Minimum Requirements for Biological Products Partial amendment to the Public Notice on National Release Testing

Updated on : 07-07-2025

Japan: Partial amendment to the Minimum Requirements for Biological Products Partial amendment to the Public Notice on National Release Testing

The Minimum Requirements for Biological Products will be amended as follows:Regarding the article of “Inactivation test” in the section of “Tests on final product” of the monograph for “High dose Influenza HA Vaccine”, the rule of inoculating with the allantoic fluid into allantoic cavities of eggs in case there are positive hemagglutination test results will be partially amended. And regarding the standard for “Pneumococcal Polyvalent Vaccine”, the section of “Serological identification test” will be deleted. In addition, the standard for “21-valent Pneumococcal Conjugate Vaccine” that is to be newly approved will be added.The Public Notice on National Release Testing will be amended as follows: The criterion, fee, quantity and Institution for National Release Testing for “21-valent Pneumococcal Conjugate Vaccine” that is to be newly approved will be added.

Download: Japan: Partial amendment to the Minimum Requirements for Biological Products Partial amendment to the Public Notice on National Release Testing

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