Drugs

FDA Globalization Initiatives

With the number of shipments of FDA-regulated products into the U.S. more than doubling from 15 million to more than 34 million in the past decade, the agency is implementing initiatives to keep pace, according to deputy commissioner for global regulatory operations and policy Howard Sklamberg. Writing in an FDA Voice blog post, Sklamberg says that the products are handled by 130,000 importers and are manufactured, processed, or packaged at more than 300,000 foreign facilities.

“We know this global trade expansion has ramifications for our nation’s public health,” he writes. “We also know we cannot be the inspectors for the world. Hence, we need to effectively direct our resources in a risk-based manner as we grapple with this tremendous volume of imported goods.”

One way to keep up, he says, is to identify foreign regulators to partner with in verifying that safety standards are being met and then construct an approach that will meet the requirements of multiple regulatory jurisdictions. He describes two programs involving medical devices and drugs that meet the challenge.

First, the Medical Device Single Audit Program is an international approach to the auditing and monitoring of the manufacture of medical devices to ensure their safety and efficacy. The program allows a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Currently, the U.S. is participating in a pilot program with Australia, Brazil, Canada, and Japan.

Second, FDA launched in 2014 the Mutual Reliance Initiative, a collaboration between the agency and European Union member states. The program’s goal is to determine if FDA and the European Union can agree to recognize each other’s good manufacturing practice inspections. “If successful,” Sklamberg says, “we could rely upon EU experts to inspect facilities within their own borders, a more practical way of overseeing the large number of drug manufacturing sites outside of the United States. And it would be similarly more practical if the EU relied on FDA experts to inspect facilities within the United States.”

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