Regulatory Programme Research: Scorecards
Scorecards
The objective of this programme is to achieve an internationally accepted balanced electronic scorecard for monitoring the quality of regulatory submissions and their review. Whilst the speed of review has a major influence on patient access to medicines, it is also important to recognise the sponsor’s role in the submission of a high-quality dossier and the regulatory agency's responsibility to conduct a quality review. With this goal in mind, over the last five years CIRS has developed and tested a scorecard for measuring the quality of the regulatory submission and the review process.
Programme accomplishments
- Developed two scorecards — one to measure the quality of the sponsor's submission and the second to measure the quality of the regulatory review
- Conducted a retrospective pilot study involving three agencies (Health Canada, Australian TGA and Swissmedic) and seven companies, with reported analysis on 42 scorecards
- Created a database that enables a profile to be constructed for each agency and company, which when analysed, identifies the areas in which organisations exceed standards and where improvements can be made