Japanese pharmaceutical and regulatory environment.
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 transformed. 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 temporary. The future of drug development lies in multinational clinical trials and simultaneous submission to the major regulatory authorities.
CEO and Chairman, SNBL Ltd, Kagoshima, Japan (Ryoichi Nagata); Medical Advisor, SNBL Ltd, Baltimore, Md, USA (Jean-David Rafizadeh-Kabe).
Ryoichi
R
Nagata
Jean-David
JD
Rafizadeh-Kabe