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Japan Amends Quasi-drug Ingredients Standard 2006

Requirements related to Japan’s quasi drug ingredients and applications for quasi-drugs manufacturing approval and marketing licenses have been changed.

On September 11th, Japan Ministry of Health, Labour and Welfare (MHLW) issued a notice to amend the specifications of 48 ingredients in the Japanese Standards of Quasi-drug Ingredients 2006 (JSQI, please refer to Cosme-List for all the lists). The revisions were promulgated on September 11, 2019. A 1.5-year grace period which will end on March 31, 2021 was granted for stakeholders to prepare for enforcement of the new requirements.

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