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Japan’s MHLW Amends the Minimum Requirements for Biological Products

September 23, 2014

Japan’s Ministry of Health, Labour and Welfare (MHLW) amended the minimum requirements for biological products to add the standard for a vaccine product to be newly approved.

The amendment aims to establish the standard for the manufacturing process, properties, quality, and storage of biological products to improve public health and sanitation of these products.

A public consultation is open for this amendment until September 15, 2014.

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