Quasi-drug

The PAL contains the specifications that are required to secure the quality, efficacy and safety of drugs (ethical and OTC drugs, quasi-drugs, cosmetics and medical devices). However, this chapter describes mainly ethical drugs. 

The PFSB consists of a Secretary General, five divisions and one office. It ensures safety and efficacy of drugs, quasi-drugs and medical devices, editing as well policies regarding blood supplies, blood products, narcotics and stimulants. 

Safety Division. The responsibility of this division is to ensure the safety of drugs, quasi-drugs, medical devices and cosmetics. The Office of Appropriate Use of Drugs, attached to this division, collects and evaluates information related to ADRs and promotes the appropriate use of drugs. 

The Health Policy Bureau handles promotion of R D, drug, quasi-drugs, medical devices and sanitary materials production and distribution policies. It is divided in two divisions, the Economic Affairs Division and the Research and Development Division, both having relationship with the pharmaceutical industry. 

Office of OTC and Generics. This division reviews applications for approval of generics, non-prescription drugs (OTC), quasi-drugs and cosmetics. 

Quasi-drugs are substances that exert a mild action on the body, such as drugs used to prevent nausea, bad breath, body odor, hair loss, heat rash and so on. 

Other standards were published for quasi-drugs (e.g. sanitary products standards), cosmetics (e.g. standards for the quality of cosmetics) and medical devices (e.g. standards for blood donor sets, for cardiac pacemakers, for medical X-ray apparatus). 

When the subcommittees are satisfied with the review report, the dossier goes back to the PFSB with a recommendation for approval. The minister will officially grant the New Drug Approval to the pharmaceutical company, through the prefecture. Around 18-24 months are necessary to obtain a new drug approval if there are no special issues, 6 months for a quasi-drug, 3 months for cosmetics and 12 months for a medical device. 

Japan Japanese standard on cosmetics, preservative for all cosmetics up to 0.1%. Japanese standard on quasi-drugs, active ingredient for toothpaste up to 0.02% Japanese standard on cosmetics, preservative for cosmetics on use to mucous membrane and cosmetics on use without rinse up to 0.3% This ingredient is not found in Japanese standard. It is necessary to register as new ingredient to MOH for new preservative for cosmetics with data on safety or for new active ingredient for quasi-drug (toothpaste) with data on safety and effectiveness... 

In the U.S. hair care products containing an antidandruff ingredient are considered as over-the-counter (OTC) drugs. However, different regulations are applied in other regions. An antidandruff shampoo is treated as a quasi-drug in Japan, a therapeutic product in Australia, and may be a cosmetic or an OTC product in Europe, depending upon the claims. 

Buildings and Facilities of Manufacturing Plants for Quasi-Drugs. 

Analysis and testing of quasi-drugs undergoing only for repackaging Other testing institutions. 

Buildings and Facilities of Import Offices for Quasi-Drugs, Cosmetics or Medical Devices... 

The buildings and facilities of import offices for quasi-drugs, cosmetics or medical devices shall meet the following requirements ... 

Economic Affairs Division. This division surveys and coordinates regulation of production, research, and trade of drugs, quasi-drugs, and medical devices. The Office of Industry Research, attached to this division, collects information related to the pharmaceutical industry and favors consultations between the industry and the Authorities. 

Pharmaceutical and Cosmetics Division. This division provides technical guidance and supervision of the production of drugs, quasi-drugs, and cosmetics, as well as services for drug approvals or licences for manufacture or import. The Office of Cosmetics, attached to this division, supervises the production of quasi-drugs and cosmetics and deals with matters related to their approval for import or manufacture. 

Directive. In the USA, the legal responsibility rests with the FDA. In Japan, the Ministry of Health, Labour and Welfare regulates the safety of hair dyes, considering them as quasi-drugs , subject to approval based on evidence of their safety, and there are similar regulations in other Far Eastern countries. 

Under the PAL, quasi-drugs (Article 2, paragraph 2) are defined as... 

In this sense, the products designated as quasi-drugs by the MHW are cotton products intended for sanitary purposes (including paper cotton) and the following products with a mild action on the human body hair dyes permanent waving products hair-growers ... 

On the other hand, all active ingredients used in quasi-drugs, as well as excipients, must first be authorized by the Japanese authorities. 

As in Japan, there are also quasi-drugs, such as oxidation hair dyes, deodorants, hair loss products, etc. 

MHW— Ministry of Health and Welfare, 1992, Guide to Quasi-Drug and Cosmetic Regulations in Japan, Yakuji Nippo, Tokyo. 

MHW—Ministry of Health and Welfare, 1966, Ordinance No. 30/1966 Ordinance to Regulate Coal-Tar Colors Permitted for Use in Drugs, Quasi-drugs and Cosmetics (as amended by Ordinance No. 55/1972 and Ordinance No. 126/2003). 

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