Sec. 2013. Encouraging international harmonization
244 words·~1 min read·
/bill/116/hr/14/ih/section-2013A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Not later than one year after the date of enactment of this Act, the Comptroller General of the United States shall issue a report evaluating— the consistency with which the International Conference on Harmonisation (in this section referred to as ICH ) guidelines on good manufacturing practices, including ICH Guidelines Q8–11, are being implemented by drug regulatory authorities across countries and international regions; whether domestic active pharmaceutical ingredient manufacturers (including any such contract manufacturers) are provided sufficient opportunity to participate with regulatory authorities in the development of guidelines prior to implementation; whether divergence from ICH guidelines or differing regulatory standards or requirements by drug regulatory authorities across countries and international regions creates— inefficiencies in drug manufacturing; incompatible requirements that can contribute to or exacerbate drug shortages; and the most common areas of divergence between ICH guidelines and regulatory standards and requirements by drug regulatory authorities across countries and international regions that, if rectified, may reduce the inefficiencies and incompatibilities identified pursuant to subparagraphs
(A)and (B). Not later than two years after the date of enactment of this Act, informed by the needs identified in the report issued pursuant to subsection (a), the Secretary of Health and Human Services, in conjunction with drug regulatory authorities across countries and international regions and the ICH, shall develop and implement a training program for drug regulatory authorities across countries and international regions to promote consistent application of and reduce divergence from ICH guidelines on good manufacturing practices.