Recent progress in life sciences, especially rapid advances in genome research, regenerative medicine and biotechnology, provide new approaches to innovative therapeutics such as cellular and gene therapy products, and gene diagnostics.

In the Division of Cellular and Gene Therapy Products (CGTP), which was newly established in April, 2002, we are engaged in the study for evaluation of the quality, safety and efficacy of cellular and gene therapy products, and diagnostic drugs.
Biochemical and molecular biological studies associated with these areas are also conducted in our division.

(Division Head)

• Yoji Sato, Ph.D. (since Apr. 2012))

Sections

• Section 1 (Gene Therapy)
• Section 2 (Cellular Therapy)
• Section 3 (Molecular Diagnosis)



• Location of CGTP

Topics

• Gene Therapy Clinical Study Protocols Approved in Japan (in "Section 1" Page)

• Examples of Oncolytic Viruses under Development in Japan (in "Section 1" Page)

• The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Gene Therapy Discussion Group
  Communication Paper (Jun. 2006) (in "Section 1" Page)

• Special Lectures in NIHS Open House (Jul. 2005)
  Presentation "Horizontal Aspects of Innovative Biologicals -in the Case of Novel Cellular/Gene Therapy Products-" by Yamaguchi, T., Ph.D. [in Japanese]

• Current Status of Cellular Therapy Using Human Cell/Tissue Products in Japan [in Japanese] (in "Section 2" Page)

• NIHS Open House (Jul. 2006)
  CGTP Presentation "Future of Biochip Technology for Molecular Diagnosis " [in Japanese] (in "Section 3" Page)

• NIHS Open House (Jul. 2007)
  CGTP Presentation "Using Virus as Medicine -Gene Therapy and Virus Therapy" [in Japanese] (in "Section 1" Page)

Related Information

• Japanese Guidelines on Cellular and Gene Therapy Products
• Biologics Forum [in Japanese]
• Useful Links
• Frequency Access Ranking of CGTP Web Pages
     Year 2005    Year 2006

Publications, Presentations, etc. [partially in Japanese]

• Year 2005 (Apr. 2005 - Mar. 2006)
     Outline05    Publications05    Presentations05    Committees05
• Year 2004 (Apr. 2004 - Mar. 2005)
     Outline04    Publications04    Presentations04    Committees04
• Year 2003 (Apr. 2003 - Mar. 2004)
     Outline03    Publications03    Presentations03
• Year 2002 (Apr. 2002 - Mar. 2003)
     Outline02    Publications02    Presentations02
  
  
• Awards of Members

NIHS Homepage

Last Update: 8 April. 2012
suzuki@"mark"nihs.go.jp"