Sec. 813. Report on the pharmaceutical and personal protective equipment regulatory practices of the People’s Republic of China
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Not later than 120 days after the date of the enactment of this Act, the Director of National Intelligence shall submit to the appropriate congressional committees, and make publicly available on the internet website of the Director, a report on the pharmaceutical and personal protective equipment regulatory practices of the People’s Republic of China. The report under subsection
(a)shall include the following: An assessment of the quantity of active pharmaceutical ingredients produced annually within China. An estimate of the percentage of active pharmaceutical ingredients produced globally that originate in China. A description of the National Medical Products Administration of China, including with respect to— the roles and responsibilities of the Administration; the organizational structure of the Administration; and any affiliated institutions of the National Medical Products Administration. An assessment of the capacity of the National Medical Products Administration to effectively develop safety standards, efficacy standards, and any other relevant standards concerning the production of active pharmaceutical ingredients and pharmaceutical drugs. An assessment of the capacity of the National Medical Products Administration to enforce standards on the production and distribution of active pharmaceutical ingredients and pharmaceutical drugs. An overview of qualitative disparities between active pharmaceutical ingredients and pharmaceutical drugs approved by the National Medical Products Administration and similar drugs subject to regulatory oversight and approval in the markets of the member states of the Organisation for Economic Co-operation and Development. An assessment of the qualitative disparities between the standards and enforcement practices of the National Medical Products Administration on the production and distribution of active pharmaceutical ingredients and pharmaceutical drugs and the good manufacturing practice guidelines issued by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. An assessment of the susceptibility of the National Medical Products Administration, the subordinate organizations of the National Medical Products Administration, and other associated personnel to engage in corrupt practices, particularly practices that relate to assessing the safety of pharmaceutical ingredients and other pharmaceutical drugs within the authority of the National Medical Products Administration. An assessment of the national security risks associated with the reliance by the United States on pharmaceutical ingredients and pharmaceutical drugs originating in China, including an assessment of how and whether China could leverage its production of certain pharmaceutical ingredients as a means to coerce the United States or the partners and allies of the United States. An assessment of the percentage of personal protective equipment produced globally that originates in China. An assessment of the national security risks associated with any reliance by the United States on personal protective equipment originating in China, including an assessment of how and whether China could leverage its production of personal protective equipment as a means to coerce the United States or the partners and allies of the United States. In carrying out subsection (a), the Director shall coordinate with the Director of the Central Intelligence Agency, the Director of the National Security Agency, the Director of the Defense Intelligence Agency, the Director of the National Geospatial-Intelligence Agency, and any other relevant head of an element of the intelligence community. The report submitted to the appropriate congressional committees under subsection
(a)shall be submitted in unclassified form, but may include a classified annex. In this section, the term appropriate congressional committees means— the congressional intelligence committees; the Committee on Foreign Affairs and the Committee on Energy and Commerce of the House of Representatives; and the Committee on Foreign Relations and the Committee on Finance of the Senate.