Quality Scorecard
Goal/purpose
Enable improved quality of regulatory agency review and company submission
Overview
The Quality Scorecard provides a structured method for assessing the quality of the company submission and regulatory review based on the assessment of individual products. Developed to capture feedback from companies and regulatory authorities, it enables both stakeholders to contribute towards the optimisation of the regulatory process. The Quality Scorecard evaluates key factors that contribute to a high-quality regulatory submission and review, such as dossier content, scientific advice, conduct of the review, and communication.
The tool enables regulatory agencies to monitor the quality of their reviews, identify factors affecting performance, and strengthen relationships with industry through transparent, bidirectional feedback. By analysing aggregated responses, agencies can pinpoint areas for optimisation and support training initiatives that build quality into the medicines assessment process.
Who the tool is for
Regulatory agencies and pharmaceutical companies.
How the tool works
The Quality Scorecard is implemented through structured questionnaires completed by regulatory agencies (to assess the quality of company submissions) and/or by companies (to assess the quality of the regulatory review). Once completed, the responses are aggregated and analysed by CIRS to identify strengths, gaps, and differences in perception between agencies and companies. This feedback creates a transparent basis for identifying areas where processes or submissions can be improved, supporting continuous quality enhancement across regulatory activities.
Practical use cases
The Quality Scorecards have been utilised by regulatory agencies in Australia, North and South America, and Europe to identify major factors that affect the review and submission process. The results provided a gap analysis that was used for training purposes to build quality into the medicines assessment process and to strengthen regulatory activities overall.
WHO Global Benchmarking Tool (GBT) indicators supported by the tool
- GBT MA04.01: Documented procedures/tools are implemented for the assessment of the different parts of the application and for the assessment of specific requirements of specific classes of medical products (quality, safety, and efficacy)
- GBT MA04.10: The regulations and/or guidelines for good review practices (GRevP) are developed or recognized and implemented
Resources
- Salek S, Mallia-Milanes A, McAuslane N, Walker S. Development and Application of Scorecards to Assess the Quality of a Regulatory Submission and Its Review. Drug Information Journal. 2012;46(1):73-83.
- CIRS R&D Briefing 58: The changing regulatory environment in Latin America: Focus on good review practices.
- CIRS R&D Briefing 87: Roadmap for Regulatory Strengthening: CIRS Tools for Measuring and Optimising Regulatory Performance to support practices in line with the World Health Organization (WHO) Global Benchmarking Tool (GBT) indicators
- CIRS 2004 Workshop Report – Building quality into regulatory dossiers and the review process