Sec. 103. Reporting of mutual recognition agreements for inspections and review activities
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Not later than the end of calendar year 2020, and annually thereafter, the Secretary of Health and Human Services (referred to in this section as the Secretary ) shall publish a report on the public website of the Food and Drug Administration on the utilization of agreements entered into pursuant to section 809 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384e ) or otherwise entered into by the Secretary to recognize inspections between drug regulatory authorities across countries and international regions with analogous review criteria to the Food and Drug Administration, such as the Pharmaceutical Inspection Co-Operation Scheme, the Mutual Recognition Agreement with the European Union, and the Australia-Canada-Singapore-Switzerland Consortium, in the previous fiscal year.
The report under subsection
(a)shall include each of the following: The total number of establishments that are registered under section 510(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(i) ), and of such establishments, the number in each region of interest. The total number of inspections conducted as described in subparagraphs
(A)and
(B)of paragraph
(5)at establishments described in paragraph (1). Of the inspections described in paragraph (2), the total number of inspections in each of region of interest. Of the inspections in each region of interest reported pursuant to paragraph (3), the number of inspections in each FDA inspection category. Of the number of inspections reported under each of paragraphs
(3)and (4)— the number of inspections which have been conducted pursuant to an agreement or other recognition described in subsection (a); and the number of inspections which have been conducted by employees or contractors of the Food and Drug Administration. In this subsection: The term FDA inspection category means the following inspection categories: Inspections to support approvals of changes to the manufacturing process of drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). Good manufacturing practice surveillance inspections. For-cause inspections. The term region of interest means China, India, the European Union, and any other geographic region as the Secretary determines appropriate.
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Sec. 103
Reporting of mutual recognition agreements for inspections and review activities
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