Regulatory Trackers
Global Pharma Guidance Update
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
European Performance Tracker
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
US FDA Performance Tracker
The unusual revision of Corcept’s complete response letter suggests the FDA may be writing for a different audience now that unapproved product CRLs are being made public.
Internal stress could break the FDA's streak of consistently high novel agent approval counts, despite beginning 2026 with almost as many goal dates as the past three years even though biologics center submissions plunged.
The FDA starts 2026 with 55 novel agents under review, which are detailed in Pink Sheet's interactive chart.
Review times for novel agents approved in 2025 stayed remarkably steady, hugging PDUFA timelines, maintaining high approval volumes, and foreshadowing a new debate over whether ultra‑fast, politically driven reviews will result from the Commissioner's National Priority Voucher program.