§384e Recognition of Foreign Government Inspections

Summary

The Secretary can make agreements with foreign governments or their agencies to accept inspections of foreign drug establishments registered under section 360(i). These agreements can help with preapproval or risk-based inspections under the schedule in paragraph (2) or (3) of section 360(h). The Secretary may only make such agreements with governments the Secretary finds are able to inspect in line with the law. The Secretary must do any reviews and audits of a foreign government’s drug safety programs, systems, and standards that are needed to decide if they can meet those inspection requirements. Inspections done by an approved foreign government can be used as evidence that a drug maker meets the rules in section 351(a)(2)(B) or section 381(r). The Secretary can also use those inspection results for other appropriate purposes. Not later than 1 year after December 29, 2022, the Secretary must regularly check whether more of these agreements are appropriate. Not later than 4 years after December 29, 2022, and every 4 years after that, the Secretary must send a report of the findings and conclusions from those checks to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions.