FDA goes global with sharing data, regulatory resources

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As part of a new strategy to keep up with imported regulated products, the FDA said it will work with international regulatory bodies to foster safe product development globally. The agency said the strategy, titled “Pathway to Global Product Safety and Quality,” includes developing international data information systems and networks to share regulatory resources across world markets.

“Global production of FDA-regulated goods has exploded over the past 10 years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” said FDA Commissioner Margaret A. Hamburg, MD. “There has been a perfect storm—more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented.”

In a June 20 release, the FDA noted four key elements to the new strategy:

  • The FDA will partner with its worldwide counterparts to create coalitions of regulators focused on ensuring and improving global product safety.
  • The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources globally.
  • The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and IT.
  • The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

The strategy is a response to trends the agency expects to see worldwide in coming years:

  • Western economies will increase their productivity to compete with emerging markets and economies, leading to more imports and increased pressure to reinvent manufacturing processes.
  • Money, goods, data and people will increasingly and more quickly cross borders.
  • Growing demand, constrained supply and increased regulatory and social scrutiny will determine what resources are used, how they are used and the cost. Manufacturers will adopt new manufacturing processes and emerging technologies in response.
  • Governments worldwide will increasingly be called upon to mitigate the sometimes negative impacts of globalization on their citizens, making the operating environment for companies more complex.

 The full FDA report can be found here.