ing countries; to identify the main gaps in these systems; and to design a strategy the FDA and other stakeholders can use to strengthen food and medical products regulatory systems abroad.
In preparing this report, the committee heard from stakeholders from many low- and middle-income countries at conferences in Washington, DC, Beijing, São Paulo, Pretoria, and New Delhi. A brief summary of its findings and recommendations follows.
CORE ELEMENTS OF REGULATORY SYSTEMS
The committee identified the main characteristics of successful regulatory systems. First, a robust system is responsive; it can respond quickly in a crisis, and it can respond appropriately to new science and new ideas. Such a system also focuses on the outcomes and does not become overly concerned with prescribing methods that might get in the way of innovation. A robust regulatory system is a predictable system; rules are applied consistently and fairly and are designed to favor neither small nor large companies, neither imports nor domestic products. The system allocates controls proportionate to risk and regulates products with similar risks in similar ways. Finally, a robust regulatory system is independent; it is not unduly influenced by politics or money.
The main duties of a medical products regulatory authority are: product registration; the publication of clear licensure requirements; the provision of unbiased information; market entry notification; safety and effectiveness surveillance; quality control testing; inspection of manufacturers against good manufacturing practices; inspection of distributers against good distribution practices; and the evaluation of medical product performance through trials. In countries that produce vaccines, the regulatory authority is also responsible for the systematic lot release of the vaccine. The main duties of a food regulatory system are providing unbiased education and advice to all stakeholders; inspecting food production sites and processing plants against good agricultural practices and good manufacturing practices; evaluating hazard analysis and critical control points (HACCP) plans; conducting physical, chemical, and microbiological analysis of food; and doing epidemiological surveillance. These responsibilities make the regulatory system a main piece of the public health system.
Low- and middle-income country regulatory authorities are not able to execute all of these responsibilities. With this in mind, the committee identified minimal elements for a regulatory system. At a minimum, the country must have a rule-making process. This rule-making system should be open enough to allow all stakeholders to comment on new regulations. A minimally functional system also has a protocol for different agencies involved in product regulation to work together. It also has a way to identify when