Mutual Recognition Amendment Promises Improved Pharma Inspection Practices
Dara Corrigan, FDA's associate commissioner for global regulatory policy, called the agreement "an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective, and high-quality drugs."
According to an FDA news release, the United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. U.S. and EU regulators will now be able to utilize each other's manufacturing practice inspections of pharmaceutical manufacturing facilities.
The FDA and EU have been working for three years to try and allow drug inspectors to use information from inspections conducted within each other's borders. This will allow the agencies to avoid duplicating drug inspections, creating lower costs.
"The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective, and high-quality drugs," said Dara Corrigan, FDA's associate commissioner for global regulatory policy.