MHW

The Japanese regulatory authority is the Ministry of Health and Welfare (MHW) and the Pharmaceutical and Medical Safety Bureau (PSMB) is responsible for the promulgation of national and international guidelines in the form of Notifications. Guidelines are available on the Internet web-site of the National Institute of Health and Science (http //www.nihs.go.jp). The MHW has not issued specific guidance on the development of chiral drugs, but has nonetheless responded to the enantiomer-versus-racemate scientific debate. The attitude of the MHW and its advisory body, the Central Pharmaceutical Affairs Council (CPAC) is discussed in two articles by Shindo and Caldwell published in 1991 and 1995 [17, 18]. The latter paper analyzes the results of a survey of the Japanese pharmaceutical industry which sought responses on chirality issues. 

Graiunann P, Wendrich TM, Weber MHW, Schroder K, Marahiel MA (1997) Mol Microbiol 25 741... 

Infrared spectra of KBr pellets were measured on a Nicolet 10DX FTIR. Elemental analyses were performed using Parr peroxide bombs and by MHW Laboratories (Phoenix, AZ). 

Elemental Analysis. All samples submitted for elemental analysis were dried at 40 °C in a vacuum oven at less than 1 torr pressure for 24 hours and then sealed in ampoules. Elemental analyses were performed by MHW Laboratories of Phoenix, Arizona. 

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. 

Anon., Japanese Ministry of Heath and Welfare (MHW) in Notes on applications for approval to manufacture new drugs, 1975. 

Founded in 1990, the International Conference on Harmonization (ICH) is comprised of the pharmacopeial manufacturers associations in Europe (EFPIA), Japan (JPMA), the United States (PMA), and the drug regulatory agencies in Europe (EEC), Japan (MHW), and the United States (FDA), with the International Federation of Pharmaceutical Manufacturers Association (IFPMA) serving as secretariat. Pharmacopeias are not members of the ICH, where membership is reserved for three PMAs and three regulatory agencies. Invited observers include Canada, WHO, and the European Free Trade Association (EFTA). 

Duplicated elemental analysis of CR samples were carried out by the MHW Laboratory, Phoenix, Az. 

All three of the ICH regulatory parties the European Commission, FDA and MHW, made firm commitments to implement the CTD, when their representatives spoke in a panel on What the CTD will mean to Regulators in the closing plenary. 

Dr Yoshinobu Hirayama, Director, Evaluation Division 1, of the MHW Pharmaceuticals and Medical Devices Evaluation Centre confirmed that the current GAIYO (Expert Report) will be replaced by CTD Module II documents. He cautioned, however, that although the CTD provides a common content and format, there will be cases where differences would necessarily occur in dossiers for the three regions (e.g. there may be different dosage recommendations and different quality requirements). He sympathised its the impact on industry who would feel the burden of transition more than regulators and indicated that the transition time before the CTD... 

The government had required that the sponsors should have their own in-house study review board to review the ethical aspects of clinical trial protocols. Such a requirement was based on the former Japanese GCP, which stipulates that the company should organise an internal formal body or mechanism that reviews and authorises its planned studies before submitting to either study centres or the MHW for clinical trial plan notification. 

The Pharmaceuticals and Cosmetics Division (Koseisho) of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare (MHW) is the regulatory body in Japan. Also in Japan there have been clear changes in the drug approval system, mainly inspired by ICH. One of the most important recent changes is that, under certain conditions, it is now possible to use also foreign data for the approval of new dmgs in Japan. 

Muller JF, Gaus C, Prange JA, Paepke O, Poon KF, Lam MHW, Lam PKS (2002) Polychlorinated Dibenzo-p-dioxins and Polychlorinated Dibenzofurans in Sediments from Hong Kong. Mar Pollut Bull 45 372... 

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