Sec. 2014. Mutual recognition agreements for inspections and review activities
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Pursuant to section 809 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384e ), the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall establish or expand initiatives for mutual sharing of review and inspection findings between drug regulatory authorities across countries and international regions, such as through the Pharmaceutical Cooperation Inspection Scheme, the Mutual Recognition Agreement with the European Union, and the Australia-Canada-Singapore-Switzerland Consortium, to— reduce the potential for duplicative regulatory evaluation of medical products regulated by the Food and Drug Administration; and more constructively allocate appropriations to the Food and Drug Administration, including those attributable to user fees, to harmonized regulatory processes.
In carrying out subsection (a), the Secretary may expand the initiatives to include— additional countries and geographic regions with established and competent regulatory frameworks; and additional types of regulatory evaluation, including with respect to— good manufacturing practice inspections; and approval of changes to the manufacturing of drugs for which an approval or licensure is in effect 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 ).
Not later than one year after the date of enactment of this Act, the Secretary shall publish an implementation framework for the agreements to share review and inspection findings under subsection
(a)on the public website of the Food and Drug Administration. The implementation framework under this subsection shall— include the timeline for establishing or expanding initiatives described in subsection (a); describe additional types of regulatory processes that will become subject to such initiatives; specify the countries and geographic regions where such initiatives will be established or expanded; and identify additional opportunities and challenges for expanding mutual recognition agreements in drug and biologic regulation. Not later than the end of calendar year 2020 and annually thereafter, the Secretary shall publish a report on the public website of the Food and Drug Administration on the utilization of agreements described in subsection (c)(1) in the previous fiscal year. The report under paragraph
(1)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 ) and located outside of the United States, and of these establishments, the number in each region of interest. The total number of inspections conducted at establishments described in subparagraph (A). Of the inspections described in subparagraph (B), the total number of inspections in each of region of interest. Of the inspections in each region of interest reported pursuant to subparagraph (C), the number of inspections in each FDA inspection category. Of the number of inspections reported under each of subparagraphs (B), (C), and (D)— the number of inspections which have been conducted pursuant to an agreement described in subsection (c)(1); and the number of inspections which have been conducted by employees or other agents of the Food and Drug Administration. In this subsection: The term region of interest refers to China, India, the European Union, and any other geographic region as determined appropriate by the Secretary. The term FDA inspection category means refers to the following inspection categories: Inspections to support an approval of a drug 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 inspections. For-cause inspections.
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Sec. 2014
Mutual recognition agreements for inspections and review activities
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