CIRS Agenda_2015

Global Development Programme Research

Annual Mature Regulatory Agency Metrics Assessment Programme

CIRS has been collecting submission and approval data from mature agencies (US FDA, EMA, PMDA, Health Canada, TGA and Swissmedic for over ten years. Increasingly, Emerging Markets are being incorporated into global pharmaceutical development plans and agencies in these regions are evolving their systems and are collecting internal information to monitor their progress. CIRS is actively implementing a programme to collect data directly from maturing agencies to allow them to assess their own performance, provide a baseline against which the impact of change can be measured and develop realistic improvement initiatives.

Deliverables

  • Mature agencies: R&D Briefings
  • EM agencies: agency-specific performance metrics report
GDP Agency Metric

Regulatory review milestones