Japanese pharmaceutical law

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. 

Japanese pharmaceutical administration has a long story it started during the reign of Emperor Meiji, a period during which Japan reopened its frontiers to Western countries. The first law, enacted in 1874, dealt with pharmaceutical sales and handling, but it was limited to three areas (Tokyo, Osaka and Kyoto). Fifteen years later, the law covered the whole country and was merged with another law,-the Patent Medicine Law, in 1925 it was then renamed the Pharmaceutical Affairs Law in 1943. 

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. 

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. ... 

For substances not mentioned in the JP and not covered by Article 42 of the Law, additional standards were notified by the MHLW, for example, the Japanese standards for pharmaceutical ingredients, standards for crude drugs, standards of raw materials for clinical diagnostics and so on. 

Table 38.1 Subtitles that must appear in Japanese drug labeling, and the order in which they appear (after Article 52, Item 1 of the Pharmaceutical Affairs Law)...

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... 

These rules, however, were to be applied to a clinical development organization specific to Japan, and were very different from our Western ones (cf. section on Clinical Development, below). Within the framework of the International Conference on Harmonization (ICH), GCP were rediscussed for several years and finally concluded in 1996. New harmonized GCP standards are now applicable to the USA, Europe, and Japan as well, but they require profound changes of the Japanese system to be fully applied the Pharmaceutical Affairs Law... 

Japanese Office of Imported Food Safety (2006) Article 26. Implementation of inspection orders based on Section 3 of the Food Sanitation Law. Pharmaceutical and Food Safety Bureau, Department of Food Safety, Inspection and Safety Division (Notice 0331001 http //www.mhlw.go.jP/english/topics/importedfoods/dl/7.pdf). 

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. 

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