Japanese Ministry of Health, Labour, and

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. 

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. 

In Japan, the Positive List system was implemented on May 29, 2006. The Japanese Ministry of Health, Labour, and Welfare had established many provisional maximum residue limits (MRLs) in addition to present MRLs, and 586 pesticides were regulated under the Food Sanitation Law [1]. A uniform level of 0.01 ppm is established as the level having no potential to cause damage to human health [2], A rapid and sensitive multiresidue analytical method was required to conduct efficient and effective monitoring surveys of pesticide residues to ensure food safety. 

Japanese Ministry of Health, Labour and Welfare. [Relevant Documents for Abnormal Behavior No. 1-1-1. Working Group for Clinical Investigation for Oseltamivir Phosphate.] http //www.mhlw.go.jp/shingi/ 2007/05/s0514-2.html. 

The Pharmaceutical and Medical Safety Bureau (PMSB) has primary responsibility within the Japanese Ministry of Health, Labour and Welfare for administering the requirements established for the safety and efficacy of medical products under Japan s Pharmaceutical Affairs Law. This legislation was substantially amended in 1996 (with the reforms made effective in April 1997) to provide for the present medical product review and approval system. 

Sato M, Asai Y, Ando M, et al. Nationwide survey of long term ventilation and home mechanical ventilation in 1995. A 1995 annual report of the Japanese Ministry of Health, Labour and Welfare Specified Respiratory Failure Study Group [in Japanese]. 1995 106-109. 

Figure 19.1 Japanese regulatory review process. Flow of new drug application submission, review and approval. PAFSC, Pharmaceutical Affairs and Food Sanitation Council MHLW, Ministry of Health, Labour and Welfare.

Moriyama, T., Taguchi, Y., Watanabe, H. Joh, T. (2002). Changes in the cadmium content of wheat during the milling process (in Japanese). In Report on Risk Evaluation of Cadmium in Food, Research on Environmental Health, Health Sciences Research Program, Ministry of Health, Labour and Welfare, p>p. 153-160. 

Japanese Pharmacopoeia, 14th Ed. Ministry of Health, Labour, and Welfare Tokyo, Japan, 2000. 

The topic to develop harmonized guidelines on the practice of safety pharmacology was proposed to the ICH—Steering Committee by the Japanese delegates (Japanese Pharmaceutical Manufacturers Association (JPMA) and Ministry of Health and Welfare [MHW now referred to as the Ministry of Health, Labour and Welfare (MHLW)], in 1997, and adopted as the Topic S7 in 1998. The membership of the ICH S7 EWG and a chronicle of the timelines and milestones are presented in Tables 1 and 2, respectively. 

This study is supported partly by the "Research on Psychiatric and Neurological Diseases and Mental Health" from the Japanese Health Sciences Foundation the Program for Promotion of Fundamental Studies in Health Sciences of the National histimte of Biomedical Innovation (NEBIO) "Research Grant (22-5) for Nervous and Mental Disorders" from the Ministry of Health, Labour and Welfare the Kato Memorial Trust for Nambyo Research and the Neuromuscular Disease Foundation. 

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