Research Paper Series 2006

(No.31: May 2006)

Time lags between the world's first launch of new drugs
and launch in other countries
- For improving the access to new drugs in Japan -

Hiroyuki Fukuhara

  The time lags between the world's first launch and launches in other countries are surveyed for top selling drugs in 2004, and analyzed from the perspective of access to new drugs.

  The time needed for new drugs to be launched in multiple countries has been rapidly shortened in the past 20 years, and the access to new drugs has been improved considerably in many countries around the world. Although the time lag for Japan has also been shortened, the speed of change is slower than other countries. The relative order of drug launch in Japan has dropped, and Japan is recently being one of the countries where drugs are launched in the last place among 66 countries surveyed. Moreover, 30% of world's top selling drugs are not yet launched in Japan. Japan is faced with the worrying situation from the standpoint of access to new drugs.

  Improving efficiency of clinical trials through "activation of clinical studies" or "active utilization of foreign clinical data" and increasing attractiveness of Japanese market through "value-reflected drug price" or "reduction of clinical trial cost" would be effective in improving Japan's access to new drugs.

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