Pharmaceutical development and manufacturing have become global industries. But globalization has put many pressures on both industry and regulators to keep pace. Manufacturing, packaging, distribution, and clinical trials are becoming more complex as companies seek out contract organizations to set up both trials and manufacturing throughout the globe.
About 40% of finished drugs come from outside the United States, and 80% of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere. Many of these countries have regulations that are different from the U.S. Food and Drug Administration. Certainly, the International Conference on Harmonization has made progress in developing guidelines…
FDA’s Global Focus