Japan drug regulation

Fairbum WD. 1989. Japan drug regulations - a United States industrial perspective . Regulat. Affairs 1 25-33. 

Table 11.10 Veterinary Drugs Regulated as Medicinal or Feed Additive Agents in Japan...

In conclusion, the rapid evolution of the drug regulations may invalidate this chapter within a few years, but it is important for the pharmaceutical industry to understand that the whole drug environment moves toward international standards under the pressure of the scientific progress, quality requirements and economical issues. It represents a chance to integrate Japan in the conception of the global dossier, for which ICH has already laid the foundations. 

Y. Yoshioka, Regulations and guidelines on human health products in Japan, Drug Inform. 2007, 41, 163-167. 

The approved color additives appear on positive lists issued by the Food and Drug Administration in the US, the EU, and Japan, but the colorants permitted in each market vary considerably. US and EU regulatory organizations provide provisional and permanent lists of approved color additives. The permanently listed additives are considered safe for use in cosmetic and toiletry products by the regulatory bodies. Provisionally listed color additives are those on which some safety studies are still to be undertaken or their test results are under review. The Japanese regulations include only a permanent list of color additives. 

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