Vol 4 n° 4 - Drug Development
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harmaceutical regulatory change is driven by a number of factors, one of the most influential being the  harmonization  process  lead  by  the  International Conference on Harmonization of Technical Requirements for  Registration  of  Pharmaceuticals  for  Human  Use (ICH). (Detailed information and guidelines are avail- able on the ICH homepage.1) The ICH is essentially com- posed of six parties: the three major regulatory authori- ties  of  the  USA,  Europe,  and  Japan,  and  the  three corresponding associations of pharmaceutical manufac- turers. It would seem natural that the guidelines pro- duced by the ICH are international in scope and purpose. The ICH produces “soft law” regulations that are by def- inition not legally binding.An ICH guideline has no more binding power than a resolution of the General Assembly of the United Nations. Once adopted by a country, they may become as binding as law (for example, the new Japanese good clinical practice [GCP] guidelines). As with resolutions, guidelines are adopted in a consensual way and reflect the minimum status of agreement on any topic. Considering this, the ICH has been successful in harmonizing regulations from all regions into one set of rules acceptable to all. Japan has accepted the changes necessary to reach agreement. The regulatory authority The Japanese regulatory authority is not well known to the rest of the world, as is the Food and Drug Administration (FDA). Japanese information is hard to access because of differences in language and culture. It is true that the Japanese Ministry of Health, Labor, and Welfare (MHLW) is a complex organization, although any regulatory author- ity is by definition complex. Its ancestor, the Ministry of Health and Welfare (MHW), implemented many current regulations and decisions. Information on both organiza- tions is available on the Internet.2 Keywords: drug development; Japan; ethnic bridging Author affiliations: CEO and Chairman, SNBL Ltd, Kagoshima, Japan (Ryoichi Nagata);   Medical   Advisor,   SNBL   Ltd,   Baltimore,   Md,   USA   (Jean-David Rafizadeh-Kabe) Address  for  correspondence:  Jean-David  Rafizadeh-Kabe,  SNBL  Ltd,  Suite 112, The Equitable Building, 10 N Calvert Street, Baltimore, Md 21202, USA
(e-mail: jdkabe@attglobal.net) C l i n i c a l   r e s e a r c h 4 7 0 Japanese pharmaceutical and regulatory environment Ryoichi Nagata, MD, PhD, FFPM; Jean-David Rafizadeh-Kabe, MD, JD P Drastic regulatory changes in Japan since 1997 have had a considerable impact on the way new medicines are developed. The regulatory authority itself has been trans- formed. Clinical trials are now performed according to international guidelines. Clinical data generated in one area are acceptable in the rest of the world in some cases through a bridging process that is viewed as only tempo- rary. The future of drug development lies in multinational clinical trials and simultaneous submission to the major regulatory authorities. Dialogues Clin Neurosci. 2002;4:470-474.