THE United States and the European Union have agreed to extend their existing cooperation so they will be able to utilise each other's good manufacturing practice (GMP) inspections of pharmaceuticals facilities.
The amended Mutual Recognition agreement is the culmination of three years of cooperation under the Mutual Reliance Initiative, and will allow the FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other's borders.
Ultimately this will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk, a release stated.
"The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure American patients have access to safe, effective and high quality drugs," said Dara Corrigan, FDA's associate commissioner for global regulatory policy.
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