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Drug approvals and pharmaceutical affairs in Japan
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09/13/05
Quasi-drugs
Filed under: Medicinal products
Posted by: Kanri @ 10:54 am

We are receiving periodically inquiries regarding "quasi-drugs" in Japan, including about one recently mentioned. "Quasi-drugs" are the second category among all regulated medicinal products in Japan (along with drugs, medical devices and cosmetics).

It is not clear how and when the term emerged, however the origin could be traced to the first translations in 1980s of the Pharmaceutical Affairs Law (Law).

Current dictionaries only add to the confusion. English dictionaries define "quasi-" as resembling to some degree. On the other hand, the original Japanese term (iyaku gaibuhin) implies a drug used "outside" (i.e. not to be digested or injected). Bilingual (translation) dictionaries are even more helpless giving the meaning of iyaku gaibuhin as over-the-counter drug, unregulated drug (?!) and even the bizarre interpretation of AltaVista as "medicine public item".

Neither is correct. Quasi-drugs are regulated products, sold with no prescription and thus falling, although not filling up the OTC category. The category of quasi-drugs now covers much more types of products than the classical quasi-drugs (for foul body odor and breath control, hair removal, body pests extermination). The PAL in Article 2 defines quasi-drugs as not equipment or instruments and having no more than a mild effect on the human body.

The aromatic anti-Legionella cleanser for bathtubs may fit well into the definition, but how about the growing line of dietic products labeled as quasi-drugs?

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