The 4th Cellular and Tissue-based Products Subcommittee Meeting

Agenda

1. Ways to proceed discussions in the Cellular and Tissue-based Products Subcommittee (part 2)
2. Mechanism of carcinogenesis and its verification method
3. Others
   - Suggestion to develop regulations to invite external experts
   - Amendment of notification of Drug Master File

List of Handouts

• Document 1　Summary of suggestions and opinions on ways to proceed to discussions in the Subcommittees
• Document 2　Ways to proceed to discussions in the Cellular and Tissue-based Products Subcommittee
• Document 3　Major councils and committees related to the Cellular and Tissue-based Products
• Document 4　Mechanism of carcinogenesis and its verification method (based on the material submitted by Prof. Mano)
• Document 5　Suggestion to develop regulations on inviting external expert
• Document 6　Amendment of notification of Drug Master File
• Ref.　Targeted outcomes of the Subcommitteess