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Table 1 Summary of challenges, proposed strategies, and recommendations

From: Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems

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
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
  1. aThese recommendation types were defined by the authors to classify how the recommendations might be implemented:
  2. Analytics – Generating and interpreting data collected through the implementation of activities and general research
  3. Collaboration – Coordinating and communicating within and among NRAs, their stakeholders and other technical partners
  4. System development – Establishing processes, procedures and platforms to enhance and facilitate activities
  5. Workforce development – Building the capacity of staff