Regulations
Cosmetics and Quasi-Drug Regulations Based on the Pharmaceutical Affairs Act
| 1900 | Regulation on production of non-regulated patent medicines (Regulation of face lotions, toothpaste, etc., not deemed to be patent medicines) [Quasi-drugs] |
|---|---|
| 1916 | Regulation on marketing of non-patent medicines [Quasi-drugs] |
| 1932 | Regulation on non-patent medicines |
| 1943 | With the enactment of the Pharmaceutical Affairs Act preceding the previous one, the name “non-patent medicine” was changed to “quasi-drug.” |
| 1948 |
With the enactment of the previous Pharmaceutical Affairs Act the “quasi-drugs” category was discontinued Cosmetics fell within the scope of the Pharmaceutical Affairs Act Registration was effected at each place of business for cosmetics production (importation) Dishonest descriptions and false or deceptive advertising became subject to prohibition |
| 1960 | Enactment of the current Pharmaceutical Affairs Act. Changes included the revival of “quasi-drugs” category, a switch from registration to a licensing system requiring a license for each product, and the obligation to appoint a technical officer [Cosmetics]. |
| 1967 | Institution of cosmetics quality standards Institution of standards for cosmetics ingredients |
| 1980 | Introduction of use-by dates, regulation requiring labeling of designated ingredients [Quasi-drugs, cosmetics] |
| 1986 | Institution of licensing standard specific to cosmetic types |
| 1991 | Institution of approval standards for production (import) of hair dye [Quasi-drugs] |
| 1993 | Institution of approval standards for production of permanent wave preparations [Quasi-drugs] |
| 1994 |
Institution of approval standards for production (import) of medicinal toothpaste [Quasi-drugs] Introduction of segmented licensing system [Quasi-drugs, cosmetics] Partial transfer to local level of approval authority for hair-dyes, permanent wave preparations, medicinal toothpaste [Quasi-drugs] Revision of notifications of cosmetics ingredients requiring approval Introduction of type-specific approval system [Cosmetics] |
| 1995 | Transfer of industry approval authority to prefectural governors |
| 1997 | Revision of cosmetic type-specific approval standards |
| 1998 | Institution of approval standards for production (import) of bathing preparations [Quasi-drugs] |
| 1999 | Switch of topical preparations, stomach tonics, vitamins, etc., from the drugs to quasi-drugs category (newly designated quasi-drugs) |
| 2001 |
Abolition in principle of cosmetics approval system [Cosmetics] Introduction of labeling of all ingredients Institution of cosmetics standards |
| 2004 | Switch of antiflatulent, disinfectant, stomach tonics, etc., to quasi-drugs category (new scope of quasi-drugs) |
| 2005 |
Implementation of production and sale approval system Separation of production and sales business and production business Introduction of Good Quality Practices (GQP) and Good Vigilance Practices (GVP) for cosmetics |
| 2014 | Reinforcement of Adverse Effect Reporting system, Revision of “Caution” text, [Quasi-drugs, cosmetics] |
