MUTUAL RECOGNITION AGREEMENTS AND GLOBAL HARMONIZATION.

SEC. 410. MUTUAL RECOGNITION AGREEMENTS AND GLOBAL HARMONIZATION. (a) Good Manufacturing Practice Requirements.—Section 520(f)(1)(B) (21 U.S.C. 360j(f)(1)(B)) is amended— (1) in clause (i), by striking “, and” at the end and inserting a semicolon; (2) in clause (ii), by striking the period and inserting “; and”; and 111 STAT. 2373 (3) by inserting after clause (ii) the following: “(iii) ensure that such regulation conforms, to the extent practicable, with internationally recognized standards defining quality systems, or parts of the standards, for medical devices.”. (b) Harmonization Efforts.—Section 803 (21 U.S.C. 383) is amended by adding at the end the following: “(c)(1) The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in meetings with representatives of other countries to discuss methods and approaches to reduce the burden of regulation and harmonize regulatory requirements if the Secretary determines that such harmonization continues consumer protections consistent with the purposes of this Act. “(2) The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in efforts to move toward the acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices, between the European Union and the United States. “(3) The Secretary shall regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize regulatory requirements. “(4) The Secretary shall, not later than 180 days after the date of enactment of the Food and Drug Administration Modernization Act of 1997, make public a plan that establishes a framework for achieving mutual recognition of good manufacturing practices inspections. “(5) Paragraphs (1) through (4) shall not apply with respect to products defined in section 201(ff).”.