- The Americas, Asia, Africa, and Middle East division.
- The Europe and Harmonization Division.
- Memos of Understanding (MOUs): the FDA has negotiated more than 50 MOU's with foreign governments that export life science-related products to the U.S. These MOUs cover U.S. standards that the exported products must meet.
- Inspections: the FDA runs more than 1,000 inspections outside the U.S. each year of facilities that export products to the U.S. (food, medications, and other critical, regulated products). These products must all meet good manufacturing practices (GMP).
- Training: the FDA trains officials in other countries to help with inspections.
- Harmonization of guidelines: the FDA is actually leading efforts with its European and Japanese counterparts to harmonize regulatory guidelines for:
- New Drugs (International Conference on Harmonization).
- Medical Devices (Global Harmonization Task Force).
- Veterinary Medications (Veterinary Conference on Harmonization).
- Mutual Recognition Agreements: this is where the FDA relies on its European counterparts to inspect European manufacturing plants that are exporting products to the U.S. on behalf of the U.S.
The U.S. FDA: A global healthcare authority?
As most people in the life science industry around the world know, the U.S. Food & Drug Administration is the prime drug, device and diagnostic regulatory agency in the U.S., but it is also quickly becoming an international organization, if not the predominant organization around the world for establishing the key criteria for approving and regulating new drugs, devices, and diagnostics (as well food).
In a press release earlier this year (March 14), the FDA announced it had received approval from the U.S. State Department to establish eight full-time positions at U.S. diplomatic posts in China, pending authorization from the Chinese government. According to the same press release the FDA will also hire five additional local Chinese nationals to work with the FDA staff in Beijing, Shanghai, and Guangzhou.
The world according to FDA
Each division has several assistant directors with responsibility for sub-regions.
According to the FDA, U.S. imports reached over six million shipments worth $80 billion in 2000 (eight years ago). These imports enter the U.S. via 150 different ports. Although FDA inspectors review100 percent of the entry documents, they physically inspect less than one percent of the total.
FDA window dressing?
Tough regulatory environs
September 17, 2008