Japanese health authorities

The Japanese Health Authority has sent a Dear Doctor letter warning against the use of diclofenac in patients with encephalitis or encephalopathy related to influenza, which may be associated with higher mortality (41). 

The Japanese Health Authority has tightened the hepatic warnings for loxoprofen after eight reports of serious hepatic adverse events since 1997, including two deaths (2). 

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. 

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. 

Other countries have followed the U.S. lead regarding patent term extension. Japan enacted a provision effective January 1, 1986, whereby patents covering pharmaceutical products could be extended for up to 5 years. The Japanese provisions differ from the U.S. law in several ways. First, more than one patent can be extended for each product. Also, the Japanese law requires that the patent be granted 2 years before health authority approval of the product. Korea has enacted a patent term extension law very similar to that in the Japanese system. Australia has replaced its lack of renumeration system with a system based on regulatory delay. 

The Japanese are the greatest consumers of pharmaceutical products per capita in the world. The Ministry of Health and Welfare in Japan has overall responsibility to implement Japanese pharmaceutical law. Within the department is the Pharmaceutical Affairs Bureau (PAB), which exercises this authority. 

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 regulatory authority in Mexico is the Direccion General de Control de Insumos para la Salud (DIGE-CIS). The Health Secretariat issues pharmaceutical registration. Safety and efficacy must be proven by phase III clinical trials in Mexico to register drugs that are new to the Mexican market. All major pharmacopeia (/ntemahona/ Pharmacopoeia, US Pharmacopeia, British Pharmacopoeia, French Pharmacopoeia, Swiss Pharmacopoeia, European Pharmacopoeia, and Japanese Pharmacopoeia) are acceptable in Mexico. 

Under the authority of the Minister and the Vice-Minister, the Ministry of Health, Labor, and Welfare (MHLW or Koseirodosho in Japanese) is responsible for social security, public health and the promotion of social welfare. For such purposes, the organization includes (Figure 35.1) the following ... 

The PFSB, the Health Policy Bureau, with the assistance of the PAFSC, and the Pharmaceuticals and Medical Devices Agency (PMDA or Kiko in Japanese) represent the managing authorities of Japanese pharmaceutical administration, in charge of reviewing drug application for approval, reexamination or re evaluation. 

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