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 maintained by CIRS for tracking mature agencies review process:

• The Regulatory Review Times Database (RRTD), which tracks application and approval dates for approved new active substances (NASs) at six agencies (US FDA, EMA, PMDA, Health Canada, TGA and Swissmedic). The database contains over 1800 records tracking approval times back to 1997
• The Regulatory Agency Benchmarking Database (RABD), in which a common set of milestones have been identified within the review processes of FDA (CDER), EMA, Health Canada, TGA and Swissmedic. This dataset has been established with the cooperation of the agencies and contains approximately 1700 records of all NASs submitted to these agencies tracked through to their final outcomes
• Data are analysed both by year of submission and year of approval to allow comparisons between cohorts of compounds reviewed within the same regulatory environment