Activity

Activity Description

Watch the IOM committee discuss its report.

The FDA has requested that the Institute of Medicine convene a consensus study to assist FDA in identifying the core elements of needed pharmaceutical, biologics, medical device, and food safety regulatory systems development in developing countries; and in 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 and prioritizing the core elements of regulatory systems development, the consensus study will also identify:

• potential areas in which progress could be made in a 3-5 year time frame;
• priorities for FDA engagement;
• 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 the expertise that FDA has in an effort to leave a more sustainable “footprint” from both their and our resource commitments.

Specific questions to be explored shall at least include:

• What critical issues do developing country regulatory authorities face and how are they prioritized?
• In what ways do they participate in standard-setting processes, organizations and harmonization efforts?
• What issues do they face in utilizing/implementing standards in a sustainable way?
• What are the core elements of their regulatory systems and are there others that should be considered?
• What are the major gaps in systems, institutional structures, workforce and competencies?
• In what ways could those gaps be addressed?
• In what ways could the U.S. FDA help address those gaps?
• In what ways could others (as delineated above) help meet those gaps?
• In what ways could FDA partner with other to help meet those gaps?
• What recommendations have already been put forward to strengthen regulatory systems?
• What obstacles exist to implement those recommendations?
• What steps could be taken to remove those obstacles?
• What incentives and controls would be needed to support efforts?

Given that “developing countries” include a heterogeneous group of about 150 low- and middle-income countries, for the purposes of this study emphasis will be given to understanding in some depth the issues for a limited number of countries that currently are or are expected to soon become major pharmaceutical and agricultural trading partners with the USA (e.g., Mexico, Brazil, South Africa, India, Thailand, and China).