P231: Maximizing the Impact of Regional Regulatory Initiatives: A Comparative Analysis of Process Characteristics

Poster Presenter

Lawrence Liberti

Director, D.K. Kim International Center for Regulatory Science
The Kim Center/ USC DRQS
United States

Objectives

Regional Regulatory Initiatives (RRIs) have emerged as an effective approach to streamline regulatory processes in approvals; however, their heterogeneity often poses challenges for stakeholders seeking to optimize their use. This study aimed to compare characteristics to identify best practices

Method

Data were extracted from the FRPath database and analyzed for over 40 process characteristics, including types of products eligible, duration of approval, mechanism of uptake by member states, and participating regulatory agencies . The seven regional initiatives were studied.

Results

Analysis revealed significant differences in the process characteristics of the initiatives studied. For example, target approval times range from 30 to 150 days. Not all types of products were addressed by all RRIs. Review mechanisms varied from verification to abridged to full reviews and the organizational structure of the initiatives could be categorized based on distinct process models. Comparisons of uptake by member states were limited.

Conclusion

Our study provides important insights into the process characteristics of RRIs highlighting areas of strengths and weaknesses. These findings can inform stakeholders seeking to optimize the use of these initiatives by identifying key features that could be leveraged for maximum impact. Agencies can identify best practices that can optimize their pathways. Future research could further explore the impact of process characteristics on the effectiveness of these initiatives and on their return on investment.