Primarily designed for non-Japanese professionals that wish to understand the Japanese system. More than 800 documents with English translations, keep you up to date with changes resulting from the reorganization of the Japanese system in 2002, including:

• The switch from manufacturing approval to marketing approval
• The establishment of the Pharmaceuticals and Medical Devices Agency (PMDA)
• Changes to Japan’s In Country Caretaker system
• The enhancement of safety measures for biological products
• The adoption of the Common Technical Document.
  

For more information, download our Japan module factsheet.