Regulations and Regulatory Affairs in Japan

Gaiyo stands in Japanese for a summary, outline, synopsis - a concise, logical description of complex issues. The Gaiyo part of JAD Database is intended to provide its users with a basic introduction to the key concepts in the regulations governing medicinal products in Japan.

Note: In one particular case, the term "gaiyo" was widely use and was familiar to the regulatory affairs and drug development professionals prior to the introduction of mandatory CTD format in Japan 2003. Back then, it was commonly translated as “Document Summary” or “The Summary of Findings” and represented a dossier with summarized registration data enclosed in the Application Assembly for approval of new medicinal products (Japanese NDA).

Updated on July 25, 2006 | Email inquiries | Orders