Regulatory Programme Research: Benchmarking

Benchmarking

Since 1998, CIRS has been evaluating the international regulatory environment by monitoring regulatory approval times as one, basic, but informative marker. Time taken to undertake the review and timeliness of the review are believed to be the key components of a quality and predictable approval process.

Two databases are run by CIRS for tracking mature agencies review process:

•  The Regulatory Review Times Database (RRTD) that tracks application  and approval dates for approved NAS at six agencies  (US FDA, EMA, PMDA, Health Canada, TGA and Swissmedic).
• The Regulatory Agency Benchmarking Database  (RABD) where  a common set of milestones have been identified within the review processes of US FDA (CDER), EMA, PMDA, Health Canada, TGA and Swissmedic.

Data are analysed both by year of submission and year of approval to allow comparisons between cohorts of compounds (expedited, orphan therapeutic class etc) reviewed within the same regulatory environment as well as by year of approval.