domingo, 11 de marzo de 2012


Medicines regulatory support

Effective medicines regulation promotes and protects public health by ensuring that:
  • medicines are of the required quality, safety and efficacy;
  • medicines are appropriately manufactured, stored, distributed and dispensed;
  • illegal manufacturing and trade are detected and adequately sanctioned;
  • health professionals and patients have the necessary information to enable them to use medicines rationally;
  • promotion and adverting is fair, balanced and aimed at rational drug use;
  • access to medicines is not hindered by unjustified regulatory work.
Medicines regulatory support
National governments are responsible for establishing strong national medicines regulatory authorities (MRAs) with clear mission, solid legal basis, realistic objectives, appropriate organizational structure, adequate number of qualified staff, sustainable financing, access to up-to-date evidence based technical literature, equipment and information, capacity to exert effective market control. MRAs must be accountable to both the government and the public and their decision-making processes should be transparent. Monitoring and evaluation mechanisms should be built into the regulatory system to assess attainment of established objectives.
The role of WHO in the area of medicines regulatory support is two-fold. One aspect relates to the development of internationally recognized norms, standards and guidelines. The second aspect relates to providing guidance, technical assistance and training in order to enable countries to implement global guidelines to meet their specific medicines regulatory environment and needs.

U.S. Food Regulations

  • U.S. Food Regulations
Requirement of Laws and Regulations Enforced by the U.S. FDA
Food Safety and Inspection Service 
The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that meat, poultry, and egg products are safe, wholesome, and accurately labeled.
Federal Register - Online via GPO Access 
The Federal Register is the official publication for Presidential Documents and Executive Orders as well as Notices, Rules and Proposed Rules from Federal Agencies and Organizations.
U.S. FDA Press Releases
An up-to-date source of announcements from the FDA regarding food.
Federal Register
Contains a number of sites with access to the full text of the Federal Register which are also searchable by keyword.
U.S. Code of Federal Regulations
A searchable database containing the text of the U.S. Code of Federal Regulations
FDA Centre for Food Safety and Applied Nutrition
Contains information on food additives, pesticides, food labeling, inspections, HACCP and more.
Pesticides and Food Safety - EPA, USDA, FDA

Contains information from the Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) related to pesticides and food safety.