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Japan Revises the Approval Requirements for Quasi-drugs

The drafts of marketing approval standards of medicated oral-care products, hair dyes and permanent wave agents were approved and became effective on July 1, 2021; Enterprises can apply for the manufacture and sale permission of liquid toothpaste to the prefectural government; MHLW revised the list of permitted additives in quasi-drugs.

At the end of 2020, Japan MHLW unveiled three amendments for public consultation, proposing to amend the manufacturing and marketing approval standards of medicated oral-care products, hair dyes, and permanent wave agents. On June 28, 2021, MHLW released several announcements, which officially approved these three amendments and made some adjustments to the approval requirements for medicated oral-care products. In addition, the MHLW modified the List of Permitted Additives in Quasi-drugs. These amendments came into force on July 1, 2021.

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