The United States and the European Union agreed to acknowledge each other's pharmaceutical manufacturing inspections after several discussions on how it will impact the industry. The United States and the European Union used to hold separate inspections of manufacturing facilities that produce drugs, a practice that potentially led to duplications of efforts and waste of resources.
The agreement that the United States and the European Union signed is expected to limit the unnecessary expenditures that come with separate inspections. Under the agreement, the United States and the European Union will recognize each other's conclusion after inspecting manufacturing facilities, according to a report by Medical Express.
The agreement is an update to an initial accord signed in 1998 concerning the manufacturing practices of the United States and the European Union. The update entails that the United States and the European Union will use the same checklist of inspection for manufacturing facilities of pharmaceutical products.
The agreement was initially part of the Transatlantic Trade and Investment Partnership discussions under former United States President Barack Obama, RAPS reported. However, President Donald Trump recently signed an executive order that made the United States exit from the Transatlantic Trade and Investment Partnership talks.
Under the agreement, regulators of the United States and the European Union will use each other's good manufacturing practice inspections of pharmaceutical and active pharmaceutical ingredient manufacturing facilities. However, the agreement does not cover the approval of medicines.
Industry groups, including the Association for Accessible Medicines, lauded the agreement as it would result in faster processing of approval requests for manufacturing facilities. The savings that will come from the lower inspection-related expenditures will be allocated to other industry-related expenses.
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