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FDA encourages import collaboration

The US Food and Drug Administration has announced a 'global strategy' to work with other regulatory agencies to increase the safety and quality of imported products

The US Food and Drug Administration (FDA) has announced a 'global strategy' to work with other regulatory agencies to increase the safety and quality of imported products to the US.

The Pathway to Global Product Safety and Quality report is designed to tackle what Dr Margaret A Hamburg, commissioner of Food and Drugs at the FDA, has described as a "perfect storm" with global production of FDA-regulated goods increasing dramatically over the last ten years at the same time as imports of materials and ingredients for production in the US have also been growing.

According to the FDA, one of the key elements of the plan is to partner with counterparts around the world creating global coalitions of regulators.

These coalitions are expected to develop international data information systems and networks, with the sharing of data and regulatory resources encouraged.

The FDA also said the information systems will contain additional analysis capabilities, focusing on risk analytics, while the agency will "leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk."

The agency stated the changes were necessary now to tackle trends that will make importing of products an even bigger issue in the future. These trends include western economies increasing productivity to compete with emerging markets, as well as growing demand, constrained supply, and increased regulatory and social scrutiny of resources.

Recent months have seen the FDA co-operate more extensively with the European Medicines Agency (EMA), including setting guidelines for more consistent reviewing of marketing authorisation applications and extending confidentiality agreements.

The FDA said it is working to make aspects of drug regulation more reliable via the International Conference on Harmonisation. It has also joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S), an organisation of the drug manufacturing inspectorates from 39 countries.

The FDA has the report available for download.

21st June 2011


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