Cross-pond regulators pilot joint ops

Drug regulators in the U.S and Europe are becoming fast friends. Officials are talking more, according to regulator-panelists at a town hall gathering held this week at the ISPE annual meeting in San Diego. They are recognizing that they follow the same path to drug approvals despite differences in some of the methods used.

In fact, a pilot program testing joint U.S./EU inspections is underway. A handful of inspections have been completed, and while there's no sign of joint enforcement actions, regulators say they find that they usually agree on inspection results.  They are continuing the pilot and indicate they are open to the suggestion of joint inspections from those planning joint filings.

Regulators on both sides of the Atlantic are taking a harder look at manufacturers' selection and management of suppliers. Good distribution practices are part of the effort to shore up security in the supply chain in both pre- and post-approval inspections. Inspectors are scrutinizing chain of custody to confirm solid vendor-qualification efforts.

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