Pmda - Pharmaceuticals and Medical Devices Agency

Regulatory Science/The Science Board/Standard Development

The 2nd Bio-products Subcommittee Meeting

Press Release

Date and Time: November 1, 2012  from 5pm to 7pm

Agenda / List of Handouts

  1. Relationship among new drug development, review, and post-marketing safety measures
  2. Future issues to discuss
  3. Others
List of Handouts
  • Document 1 Reorganization of Offices of Biologics and their new work assignment
  • Document 2 Relations among new drug development, review and post-marketing safety measures
  • Document 3 Targeted outcomes of the Subcommittees
  • Document 4 Flow from suggestion to adoption of agendas of the Subcommittees
  • Document 5-1 Proposed agenda of the Pharmaceuticals Subcommittee
  • Document 5-2 Proposed agenda of the Bio-products Subcommittee
  • Ref.1 Overview of review for approval and post-marketing safety measures