Japanese Ministry of Health

Japanese Ministry of Health and Welfare (Former Ministry of Health, Labor and Welfare), Guidelines for Toxicity Studies of Drugs (7) Skin Photosensitization Studies, Tokyo,... 

Joint Directives of the Japanese Environmental Protection Agency, Japanese Ministry of Health and Welfare and Japanese Ministry of International Trade and Industry, 31 March 1987. 

Japanese Ministry of Health and Welfare (MHW). (1989). Revised Guidelines for Toxicity Studies Required for Application for Approval of Manufacturing/Importing Drugs. Ministry of Health and Welfare Tokyo, pp. 37—48. 

Note GLP = Good Laboratory Practice ICH = International Conference on Harmonization IND = Investigational New Drug JMHW = Japanese Ministry of Health and Welfare MAA = Marketing Authorization Application NCE = New Chemical Entity. 

The main players at ICH are now the European Commission/EMEA, EEPIA, Japanese Ministry of Health Labour and Welfare (MHLW), Japanese Pharmaceutical Manufacturers Association (JPMA), US FDA and Pharmaceutical Research and Manufacturers of America (PhRMA). The WHO, Canadian Health Protection Branch and the European Free Trade Area (BETA) countries enjoy an observer status at ICH meetings. 

Italy Japan N/A Japanese Ministry of Health and Welfare... 

Relationships are looser in some countries. The health authority of Canada claims that the Canadian GMP guidelines of 2002 [16] have been revised in line with the PIC and the WHO guides as well as the GMP guide on APIs produced by ICH. (See below.) The Japanese Ministry of Health, Labor, and Welfare (MHLW) explains that ordinance no. 3 as the legal base for GMP requirements in Japan [17] has been drawn up taking into account both the relevant paragraphs of the U.S. CFR, parts 210 and 211, as well as the WHO guide. 

Japaa In Japanese Food Law, synthetic and naturally occurring additives are treated differently. The latter, in particular naturally occurring flavors and vitamins, do not require any special permission for use. The Japanese Ministry of Health and Welfare (MHW) is responsible for the approval of color additives which are outlined in a positive list of approved colors. MHW allows petitions for the addition of a new colorant to the list. Synthetic dyes permitted for food coloring in Japan include food dyes approved in the EU or/and in the USA (Table 5.7). 

The Japanese Ministry of Health, Labour and Welfare, and the Japan Pharmaceutical Manufacturers Association. 

Risk assessment activities of IPCS are supported financially by the Department of Health and Department for Environment, Food Rural Affairs, United Kingdom Environmental Protection Agency, Food and Drug Administration, and National Institute of Environmental Health Sciences, USA European Commission German Federal Ministry of Environment, Nature Conservation and Nuclear Safety Health Canada Japanese Ministry of Health, Labour and Welfare and Swiss Agency for Environment, Forests and Landscape. 

The International Conferences was jointly supported and organized by the Commission of the European Communities (CEC), the US Food and Drug Administration (FDA), the Japanese Ministry of Health and Welfare (MHW), together with the pharmaceutical industry, as represented by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), the European Federation of Pharmaceutical Industry Associations (EFPIA), the US Pharmaceutical Manufacturers Association (PMA) and the Japanese Pharmaceutical Manufacturers Association (PMA). 

Japanese Ministry of Health and Welfare (1993), Guideline on Control of Computerised Systems in Drug Manufacturing, Manual for Control of Computerised Systems in GMP, Audit Manual for Manufacturers of Pharmaceutical Product with Computer Systems. 

Koseisho (1988), Good Laboratory Practice Attachment GLP Inspection of Computerised Systems, Pharmaceutical Affairs Bureau, Japanese Ministry of Health and Welfare, Tokyo. 

Japanese Ministry of Health and Welfare (1997), Regard to Retention of Records by Using Magnetic Media, Concerning Manufacturing Control and Quality Control of Pharmaceutical Products and Medical Devices, Open Letter to Every Prefectural Health Lead Officer, Inspection Guidance Division of Pharmaceutical and Medical Safety Bureau, September 18. 

Japanese Ministry of Health, Labor, and Welfare (MHLW)... 

Notification No. 698, Pharmaceutical Affairs Bureau, Japanese Ministry of Health and Welfare, Tokyo, 1980. Draft Policy to Handle Stability Data Required in Applying for Approval to Manufacture (Import) Drugs and Draft Guidelines on Methods to Perform Stability Test. Ministry of Health and Welfare The First Evaluation and Registration Division, Pharmaceutical Affairs Bureau, 1990. 

Outside the United States, the Organization for Economic Cooperation and Development (OECD) publishes GLPs that have been adopted by its members and the European Union. These GLPs apply to the testing of chemicals to obtain information about their properties and/or their safety with respect to human health and the environment. The Japanese Ministry of Health and Welfare (MHW) has also published GLPs that apply to non-clinical laboratory safety studies that support applications to manufacture or import drugs or applications to re-examine new drugs in accordance with the country s Pharmaceutical Affairs Law. ... 

Japanese Ministry of Health and Welfare. Information on adverse reactions to drugs. Peripheral nerve damage due to thiamphenicol. Jpn Med Gaz 1977 20 12. 

In Japan, an unusual disease named "itai-itai byo" or ouch-ouch disease" was reported in 1955 [2]. This disease is characterized clinically by bone and kidney damage. In 1968, fhe Japanese Ministry of Health and Welfare concluded that itai-itai disease was caused by... 

In Japan, there has been harmonization with the other regions in the area of toxicology (animal studies) the Japanese Ministry of Health, Labor and Welfare (MHLW) accepts appropriate foreign animal data and animal safety studies performed according to ICH guidelines. Indeed, Japan has played a major role, and its then current fertility and reproductive animal studies requirements have been adopted by the other two regions. 

The Japanese Ministry of Health defines functional food as a processed food with ingredients that, in addition to their nutritional-physiological properties, serve to... 

In 1982, the Japanese Ministry of Health and Welfare issued GLP standards for safety studies on drugs. This was followed in 1984 by GLP standards issued for studies on industrial chemicals by the Japanese Ministry of International Trade and Industry and GLP standards issued for toxicological studies on industrial chemicals by the Japanese Ministry... 

Based on Step 4 of the ICH Good Clinical Practice (GCP) guideline of May 1996, the Japanese Ministry of Health and Welfare (MHW) prepared an amendment to the previous GCP guideline and on 27 March 1997 this was issued as MHW Ordinance of the Standards for Good Clinical Practice . This new GCP became effective as of 1 April 1997 with some moratoria (preparation of standard operating procedures (SOP) at medical institutes, source data verification, etc.), and full implementation was from 1 April 1998. Unlike the previous GCP guidelines, the new GCP is based on the revised Pharmaceutical Affairs Law of June 1996, which requires... 

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