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

^aThese recommendation types were defined by the authors to classify how the recommendations might be implemented:

Analytics – Generating and interpreting data collected through the implementation of activities and general research

Collaboration – Coordinating and communicating within and among NRAs, their stakeholders and other technical partners

System development – Establishing processes, procedures and platforms to enhance and facilitate activities

Workforce development – Building the capacity of staff