Japanese Guidelines

C. Japanese guideline criteria for validation protocol of specific allergenic ingredient detection... 

Table 8.2 presents a comparison of ICH, FDA, European, and Japanese guidelines. 

ICH Stage FDA Guidelines Great Britain and EEC Guidelines Japanese Guidelines EPA OPPTS, OECD and FDA Redbook Guidelines... 

Guidelines for General Pharmacology Studies — Japanese Guidelines for Non-clinical Studies of Drugs manual 1995... 

Anon., Guidelines for general pharmacology studies-Japanese guidelines for non-clinical studies of drugs manual 1995 (pp. 71-80), Eds., Nippo Yakuji, Ltd. 

Japanese Ministry of Health and Welfare. Japanese Guidelines for Nonclinical Studies of Drugs Manual 1995, Yakuji Nippo, Ltd. 

EEC and Japanese guidelines deviate considerably from those in the USA with regard to the recommended test duration. In the EEC and Japan the test duration depends on the expected duration of the clinical treatment. Products for single use (or for single day treatments with more than one application) need to be tested for only 2 (EEC) or 4 (Japan) weeks. Clinical applications for up to 7 days require tests to be carried out for at least 4 weeks, products for an intended use up to 30 days should be tested for at least 3 months, a longer clinical treatment requires tests for at least 6 months. Japan demands tests over 12 months if the product is to be applied for more than 6 months. Three month chronic toxicity tests are most common and the minimum for products for food-producing animals. 

The mentioned differences between the US, EEC and Japanese guidelines are only the major ones. Other differences concern the definition of organogenesis periods and the related treatment periods for the different species, as well as the type of recommended investigations. Depending on the regulating authority (e.g. for human or veterinary products) test recommendations can even vary within one country. 

Inveresk research international. Rodent carcinogenicity and chronic toxicity. A review of test protocols for pharmaceuticals, agrochemicals, food additives and industrial chemicals according to European, American and Japanese guidelines. Regulatory Guidelines 1990, 1, 1-13. 

In the licensing process, it is essential for each regulatory authority to recognize as equivalent those test procedures that have been harmonized and adopted as validated methods by the PDG. This concept is already included in the Japanese Guidelines for Preparation of Section B of the Documents Accompanying New Drug Applications as of September 1995 in its assertion that, The analytical procedures in the Japanese Pharmacopeia and other compendia and those which are accepted through international harmonization are considered to be validated methods. ... 

Japan The objective of general pharmacological studies is to examine extensively the kind and potency of actions other than the primary pharmacological actions, predict potential adverse effects likely to manifest in clinical practice. .. (Japanese Guidelines, 29 January 1991)... 

The purpose of the drug label is stated succinctly in the Japanese guidelines ... 

TABLE 15.3 Japanese Guideline Criteria for the Validation Protocol for Food Allergenic Ingredients... 

Japanese Guideline on Computer Systems in Drug Manufacturing-Scope of Application... 

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