1. Gene therapy: Regulatory issues and international approaches to regulation;Cohen-Haguenauer;Current Opinion in Biotechnology,1997
2. New drug approval process in Japan;Hawakawa;Current Opinion in Biotechnology,1999
3. http://checknomics.com/industryOverview.aspx?IID=51-51&cat=574CC744&Iname=Pha – This web site provides information for purchase regarding the approval process in Japan.
4. http://www.ich.org/ – International Conference on Harmonization (ICH) (Regulatory authorities of Europe, Japan, and the United States).