SECTION C: DESCRIPTION/SPECIFICATION/WORK STATEMENT
FDA has requested that the Institute of Medicine convene a consensus study to assist FDA in (1) identifying the core elements of needed regulatory systems development in developing countries; and (2) prioritizing these needs and recommending a strategic approach to FDA’s moving forward to address regulatory capacity needs in the context of globalization. In addition to identifying the core elements of regulatory systems development, the consensus study would also identify potential areas in which progress could be made in a 3- to 5-year timeframe; priorities for FDA engagement; and areas to which others (bilateral donors, development banks, foundations, academia, industry and non-governmental organizations) are best suited to contribute and how FDA might best “partner” with these other institutions to bring to their efforts that expertise that FDA has in an effort to leave a more sustainable “footprint” from both their and our resource commitments.
Questions to be explored by the consensus study committee shall at least include
1. What critical issues do developing country regulatory authorities face? How are they prioritized?
2. In what ways do they participate in standard setting processes, organizations and harmonization efforts?
3. What issues do they face in utilizing/implementing standards in a sustainable way?
4. What are the core elements of their regulatory systems, and are there others that should be considered?
5. What are the major gaps in systems, institutional structures, workforce and competencies?
6. In what ways could those gaps be addressed?
7. In what ways could the U.S. FDA help address those gaps?
8. In what ways could others (as delineated above) help meet those gaps?
9. In what ways could FDA partner with others to help meet those gaps?
10. What recommendations have already been put forward to strengthen regulatory systems?
11. What obstacles exist to implement those recommendations?
12. What steps could be taken to remove those obstacles?
13. What incentives and controls would be needed to support efforts?