Japan Revises Standards for Quasi Drugs Additives

Japan PMDA released “Standards for Quasi Drugs Additives 2016”, a revision of the Standards 2015. There are no big changes to the Standards.  The contents of IB-0028 non-woven fabric have been deleted. The changes are applicable to future application for marketing approval.

The Standards totally includes 28 additives that had been acknowledged as quasi drugs but weren’t added to Japanese Standards of Quasi-drug Ingredients 2006, such as dicaprylyl carbonate, atelocollagen, euphoria longana extract, hydroxypropyl-beta-cyclodextrin, water soluble collagen, anhydrous zinc sulfate, zinc glycinate, water-solubility placental extract. And it specifies the following information relating to the additives:

• Order number
• Japanese name
• Origin and amount of additives or labeling requirements
• Properties
• Validation test
• Purity test
• Dry decrement, evaporation residue or moisture
• Quantitative method
• Reagent and preparation

Applicants using any of the 28 additives applying for marketing approvals they need to fill the order number in the application form rather than submitting documents related to the specifications of the additives.