Pharmaceutical Technologist - January 2008 - (Page 14)

Lagging Japanese drug R&D Japanese clinical development seems slow and inefficient, and statistical data suggest lagging drug approvals in Japan. There is a distinct lack of involvement and help from ordinal physicians for clinical trials compared with the US, and even within Japanese pharmaceutical companies there are few physicians involved in drug development. The review process for new drug approvals in Japan is also tedious and inefficient, but the Japanese Ministry of Health, Labour and Welfare proposed a ‘Three-Year Plan for National Clinical Trial Revitalization’ in 2003. Under this plan, several programmes to accelerate drug approvals are now underway. In this article, the outcomes of such efforts and the number of approved drugs in Japan are observed. Issues such as Japanese specific adverse effects are also noted. Hajimu Morioka he Japanese Ministry of Health, Labour and Welfare (MHLW) published a report stating that 210 new chemical entities (NCE) were approved in Japan during 1998–2001, but only 66 of these (31%) were developed by domestic companies and had clinical trials initiated in Japan.1 The remaining 144 (69%) were introduced by foreign pharmaceutical companies after completing overseas clinical development. Among the top 160 drugs sold worldwide in 2003, 56 (35%) were first launched in the UK, 50 (31%) in the US, 30 (19%) in Germany and 13 (9%) in France.2 Only 11 (7%) were first launched in Japan, and Japanese pharmaceutical companies have not recently developed and launched any blockbuster drugs. The drug developing capacities and abilities of Japanese pharmaceutical companies became weak after the bubble economy era in the early 1990s. T Even Japan’s largest pharmaceutical company, Takeda Chemical Co., did not launch any products from 1998 to 2005 until Rozerem (ramelteon, TAK-375) was launched outside Japan in 2005. As of yet, the company has not submitted a drug application for Rozerem to the Japanese authority because of a delay in clinical trials. In 2002, 43 drugs were approved and launched overseas, but none have been officially launched in Japan. Those who wish to receive these unapproved — yet advanced — drugs must request their doctors to import them, which is a very expensive option. It is important to analyse this delay. Drugs developed and approved overseas are introduced in Japan much later. On average, it takes approximately 6.2 months for drugs to be approved in Europe after they have been approved (and developed) in the US.3 Of the 14 JANUARY 2008 PHARMACEUTICAL TECHNOLOGIST

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Pharmaceutical Technologist - January 2008 Contents Editor's Comment News Morpheus Market Watch Lagging Japanese Drug R&D Croatia’s Innovation Integrating PAT with Biopharmaceutical Development and Manufacture Q&A

Pharmaceutical Technologist - January 2008

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