Summary

Language: English

Japan, being the second largest individual pharmaceutical market behind the USA and having the highest life expectancy in the world, is an aging society and its health insurance system is increasingly burdened by this demographic development. As the Japanese government seeks to maintain a healthy economic outlook, it must also adopt policies that continue to restrict overall health expenditures. One approach is to increase the use of low cost generics. As the result, its generic market, expected to grow significantly in the following years, is becoming a major focus for global players.

Japan has only recently revised its Pharmaceutical Affairs Law (PAL), enforced in April 2005. The revision came with a far-reaching re-organization of the health authorities and a variety of new or changed regulations.

Although Japan is a member of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) it has restricted this harmonization process towards new and innovative drugs and has excluded generics to a great extent.

Consequently, generic applicants in Japan still need to use the former Japanese submission format. The Common Technical Document (CTD), a structure for application dossier designated by the ICH to be used across Europe, Japan and the United States, is not yet accepted for generics. Furthermore, the assessment of shelf life and purity of generics in Japan follows different rules compared with innovative drugs and generics in other countries. Drug specifications and corresponding analytical methods are extra in Japan. They have to comply either with the relevant entries in the Japanese Pharmacopoeia (JP) or must follow the innovator drug product. In the latter case, they are communicated at short notice by regulatory deficiency letters.

Japan set the Japanese version of the ICH Good Clinical Practice Guideline (J-GCP) into effect in 1997 and revised it in 2006. Study conditions are comparable to the other two ICH regions with the exemption of extensive in vitro BE studies demanded for oral solid dosage forms in Japan. The most crucial difference is that Japan requires Japanese study subjects with standard Japanese lifestyle habits for clinical BE studies.

In contrast to Japan, both of the other ICH regions; the USA and the European Union (EU), are successfully applying current international quality standards to their generic products. Manufacturers from these countries therefore struggle with the different regulatory requirements, an opaque regulatory system in combination with extensive cultural differences when they try to get their products approved for the Japanese market.

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