7200AA23RFI00015 - SMPQAS Activity Market Research.pdf

Request for Information (RFI)

Request for Information Number: 7200AA23RFI00015 Issuance Date: September 29, 2023 Closing Date: October 13, 2023, 17:00 Eastern/Washington, DC Time

Subject: Strengthening Medical Product Quality Assurance (QA) Systems Activity Market Research, Bureau for Global Health

To: All Interested Respondents/Parties:

The United States Agency for International Development (USAID) through the Bureau for Global Health (GH) is publishing this Request for Information (RFI) to obtain information and input from all interested entities for the Strengthening Medical Product Quality Assurance (QA) Systems Activity. The information will be used to help make planning decisions and may inform activity design to improve future development outcomes.

This RFI is issued to collect expert industry inputs solely for information-gathering and planning purposes.

This RFI does not constitute a Request for Applications (RFA) or a Request for Proposals (RFP). Responses to this RFI are not applications or official proposals and will in no way be deemed to form any binding agreement with the RFI-issuing authority. Please do not submit applications, proposals, or resumes as they will be discarded. Proprietary information should not be sent. USAID may use any information provided without incurring any obligation. USAID reserves the right to, or not to, incorporate any, some, or none of the comments received from this RFI into any subsequent solicitations or design documents.

Anticipated Term: TBD Proposed Mechanism Type: TBD

THIS IS NOT A FUNDING OPPORTUNITY. This RFI must not be construed as a commitment by the U.S.

Government to issue any solicitation, award any grant, or pay for any information submitted as a result of this request. Responders are solely responsible for bearing all expenses associated with preparation and submission of the response to this RFI.

It is the potential responder's responsibility to monitor the site for the release of any further information.

It should be noted that responding to this RFI will not give any advantage to any organization in any subsequent procurement. All types of organizations and firms are strongly encouraged to provide information/comments. Any information submitted in response to this notice is voluntary.

All responses must be submitted electronically in accordance with the instructions provided in the RFI in English to ohs_marketresearch@usaid.gov. Responses to this RFI will be accepted through the dates noted at the top of this letter. No basis for claims against the U.S. Government shall arise as a result of a mailto:ohs_marketresearch@usaid.gov response to this request for information or from the U.S. Government’s use of such information. USAID is not responsible for any costs incurred in responding to this RFI.

RFI and Submission Instructions:

Through this RFI, GH seeks ideas, comments, and information from the public on medical product QA systems strengthening that will assist in developing a program that will most effectively advance the topic areas described below. GH asks that the public submit short submissions (must be no more than 15 pages) outlining recommendations or other information pertinent to the design and implementation of sustainable medical product QA systems at the global/regional and/or country level. Responses should clearly tie back to whatever question is being addressed, but submissions do not need to address all questions listed. All responses should provide sufficient detail and justification explaining why a certain recommendation is offered. Please also provide your name, title, organization, and contact information in the response. USAID reserves the right to potentially issue subsequent RFIs on this topic that target more specific questions or approaches. All submissions must adhere to the following to ensure an efficient review:

● Must be in English, size 11 Calibri font, no more than 15 pages total. Graphics’ subtext may use a smaller font size.

● Submission file should be in PDF or Microsoft Word format.

● Submission file should be saved as “7200AA23RFI00015 - (Respondent Organization)”.

● Subject line for submission email must include [7200AA23RFI00015]

● Must be submitted to ohs_marketresearch@usaid.gov by the Closing Date and Time noted at the top of this letter.

Thank you for your interest in responding to this RFI. Please visit www.workwithusaid.org to learn more about partnering with USAID.

Best, Imran J. Mahmud Contracting & Agreements Officer

M/OAA/GH/GHI

USAID/Washington mailto:ohs_marketresearch@usaid.gov http://www.workwithusaid.org/

Request for Information 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,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?

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?

1 e.g, Southeast Asia Regulatory Network (SEARN), Association for Southeast Asian Nations (ASEAN), African

Medicines Regulatory Harmonization (AMRH), and African Medicines Agency (AMA)

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]