FDA Moves to Greater GMP Information Sharing

The FDA is moving closer to greater use of GMP inspection information from foreign health regulators, Commissioner Andrew von Eschenbach indicated at a recent House Oversight and Investigations Subcommittee hearing.
 
The FDA has used information from foreign health regulators in determining inspection priorities. It currently is assessing the effectiveness of an unidentified foreign regulatory agency for more systematic use of information sharing, he said.

When the European Medicines Agency launched its EudraGMP database of GMP certificates earlier this year, the FDA said it would request access to the system to help it determine surveillance priorities.

Von Eschenbach also said the FDA was continuing negotiations with the Chinese State FDA and the General Administration of Quality Supervision, Inspection and Quarantine for an agreement on the safety of exported drugs and medical devices.
 
“I believe these talks are yielding significant progress toward achieving … strong, action-oriented documents,” von Eschenbach said.