February 2012 Slide of the month

In 2004 CIRS, in collaboration with Cardiff University, initiated a project to evaluate the quality of dossiers submitted for new medicines and the quality of their regulatory review.  Two Scorecards were generated to enable an effective feedback mechanism that will facilitate the improvement of quality in both the submission and review of new dossiers, one to be completed by the regulatory agencies and one by the pharmaceutical companies.

This slide shows the parameters found to be important in evaluating the quality of the dossier. The results of a feasibility study for the Scorecards, undertaken amongst three agencies and four companies has recently been published in 2012 January issue of the Drug information Association Journal entitled “Development and application of Scorecards to assess the quality of a regulatory submission and its review.“ 

This work is progressing, and a study will be initiated in 2012 to develop the next version of the Scorecards by identifying how each parameter currently measured should be weighted so that a balanced Scorecard can be developed for testing by both agencies and companies.