Table 1 Summary of challenges, proposed strategies, and recommendations
Challenge | Proposed Strategy | No. | Recommendation | Recommendation Typea |
|---|---|---|---|---|
Implement value-added regulatory practices that utilize available resources | Advance and leverage convergence and reliance initiatives | 1 | Document and communicate current reliance and convergence efforts and develop supporting infrastructure and tools to facilitate implementation | Analytics |
2 | Strengthen capacity building networks | Collaboration | ||
Institutionalize sustainability | 3 | Define needed capacities in NRAs using the WHO global benchmarking tool | Analytics | |
4 | Establish stable and transparent financing mechanisms | System development | ||
Utilize risk-based approaches for resource allocation | 5 | Perform risk analysis and implement risk management | Workforce development | |
6 | Develop systems to monitor and evaluate the impact of risk-based approaches for resource allocation | Analytics | ||
Timely access to new quality-assured medical products without compromising safety and efficacy | Strengthen registration efficiency and timeliness | 7 | Establish and refine value-added registration processes, resources, and systems | System development Collaboration |
8 | Build value-added technical capacity of assessors | Workforce development | ||
Strengthen inspection capacity and effectiveness | 9 | Enhance information sharing and use and reliance on existing inspection resources | Collaboration | |
10 | Build capacity of multi-disciplinary teams of inspectors | Workforce development | ||
Limited evidence-based data to support post-marketing regulatory action | Develop and implement risk-based post-marketing quality surveillance systems | 11 | Establish recognition of the value for risk-based post-marketing quality surveillance throughout the supply chain | System development |
12 | Develop and implement risk-based post-marketing quality surveillance programs, supporting tools, and communication strategies | Analytics Workforce development | ||
Strengthen regulatory management of manufacturing variations | 13 | Develop and implement risk-based programs to incorporate post-marketing manufacturing variations into marketing authorizations | Analytics System development |