7200AA23RFI00015 - Questions (Word Version).docx

Request for Information (7200AA23RFI00015) Bureau for Global Health (GH) Strengthening Medical Product Quality Assurance (QA) Systems Activity Market Research

Goal: Sustainably strengthen medical product QA systems, including regulatory systems and regional manufacturing, in low- and middle-income countries (LMICs)

RFI Questions for Response:

Technical Approaches (applicable at the global/regional/country level):

Priority Barriers and Opportunities:

1. What are the top 3 most significant barriers or challenges to assuring medical product quality and its impact in making and sustaining progress on achieving country and global health goals?

2. Within your area of expertise, what are the main opportunities to improve existing medical product QA systems in LMICs and which global, regional, and/or national system actors should be engaged?

3. What are the emerging areas or future needs that USAID should prioritize for country medical product QA systems strengthening (meaning that produce long-term, sustainable improvements)?

4. What innovations, goods, or new thinking that are relevant to medical product QA systems strengthening should USAID pay attention to?

Responsible LMIC Pharmaceutical Market Growth:

5. What are the top 3 barriers or challenges that need to be addressed to improve responsible LMIC pharmaceutical markets (e.g., trade, demand, pricing, proliferation of substandard and falsified/illicit products, other enabling environment factors)? And what approaches have proven effective in addressing these factors?

6. Given the expected growth of the pharmaceutical sector in LMICs over the next 10 years, how can USAID contribute to responsible growth of manufacturing capacity for quality-assured medical products?

7. What approaches should USAID consider for supporting LMICs addressing environmental and climate impacts of pharmaceutical manufacturing?

Regulatory System Strengthening:

8. What approaches should be promoted to strengthen medical product regulatory capacity (both institutional and workforce capacity) in LMICs? What measures can be taken to sustain improved regulatory capacity (i.e., WHO GBT maturity level)?

9. How can USAID best support regulatory convergence/harmonization/reliance networks in Africa, Asia,[footnoteRef:1] and elsewhere to strengthen convergence of medicines standards and product quality regulation that introduce efficiencies and improve access to quality, safe, efficacious, and affordable medical products? [1: e.g, Southeast Asia Regulatory Network (SEARN), Association for Southeast Asian Nations (ASEAN), African Medicines Regulatory Harmonization (AMRH), and African Medicines Agency (AMA)]

10. How could USAID support regulatory authorities to strengthen their enforcement capabilities related to falsified/illicit and substandard medical products, including taking timely and appropriate regulatory action to protect consumers and hold actors accountable?

Local Systems and Capacity Strengthening:

11. How can USAID strengthen the capacity of nontraditional partners (including, but not limited to, local entities and institutions) to lead and/or implement technical assistance programs that strengthen medical product QA systems?

12. How can USAID strengthen engagement of multisectoral actors with a direct or indirect impact on medical product QA (e.g, law enforcement including anti-corruption commissions, trade, finance, customs, tax entities etc.)?

Research and learning agenda:

13. From your perspective, what are some of the unanswered learning questions that would advance thinking in the field of medical product QA systems strengthening?

Closing:

14. Is there anything we have not already touched on that you would like to add?

[END OF REQUEST FOR INFORMATION]

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