- Before a European drugmaker can market a product stateside, the Food and Drug Administration must conduct an inspection of its manufacturing facility, even if foreign regulators have already given it the all-clear. It's a provision that costs time and resources, but a new amendment should lessen the burden.
- The FDA and European Medicines Agency jointly agreed to amend the pharmaceutical rules outlined in the U.S.-EU Mutual Recognition Agreement of 1998 so that inspections conducted by each party in their respective territories can be used by the other for determining whether facilities meet good manufacturing practice (GMP) standards.
- "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," the FDA wrote in a March 2 statement.
The FDA has had the power to enter such pacts so long as the partnered country meets the agency's compliance standards since 2012, when Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). The EU, meanwhile, is already involved in similar agreements with Australia, Canada, Israel, Japan, New Zealand and Switzerland.
The new agreement followed three years of talks between the U.S. and EU. With 28 countries comprising the latter of those two, the FDA was permitted to observe 14 inspections run through the EU's Joint Audit Programme — each of which involves two member nations evaluating a third nation — to make sure they satisfied the provisions of the FDASIA.
"The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the U.S. have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines," the EMA said in a release, also stating that 40% of drugs marketed in the EU and 80% of active pharmaceutical ingredients are manufactured abroad.
"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," Dara Corrigan, FDA’s associate commissioner for global regulatory policy, said in the statement.
The U.S.-EU Mutual Recognition Agreement effected electrical equipment, electromagnetic compatibility testing services, medical devices, pharmaceuticals, recreational craft and telecommunications industries. The legislation applied to nearly $50 billion worth of trade, and Congress anticipated it would save the U.S. $1 billion in regulatory costs each year, according to the Institute for International Economics.