Collaboration Through Mutual Reliance Brings FDA and EMA to the Table
In the past ten years, the number of U.S. FDA-regulated shipments moving through 300 U.S. ports has doubled. These products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities. These numbers illustrate the level to which foreign production of FDA-regulated goods and materials has exploded over the last decade.
Susan Laska, Senior Advisor for Medical Products and Tobacco Operations, Office of Regulatory Affairs, FDA, shared these figures in the opening slides of her Oct. 18 presentation, “FDA’s Mutual Reliance Initiative,” at the 12th Annual PDA Global Conference on Pharmaceutical Microbiology. Her talk offered a look at the new Mutual Reliance Agreement between FDA and the European Union. In March, both agencies signed an agreement to allow U.S. and EU regulators to use the other agency’s GMP inspections of pharmaceutical manufacturing facilities, a culmination of three years of hard work between the two agencies. The Agreement comes at a time when globalization of the pharmaceutical industry is changing the Agency’s approach to inspections, necessitating greater collaboration with other regulatory agencies.