implementation, including the examination of individual cases. Industry generally reports progress as a result of the change, but implementation of the commitment has been inconsistent, resulting in patent invalidations that create uncertainty and potentially undermine incentives to innovate.
The United States continues to have concerns about the extent to which China provides effective protection against unfair commercial use of, as well as unauthorized disclosure of, and reliance on, undisclosed test or other data generated to obtain marketing approval for pharmaceutical products. China has undertaken commitments to ensure that no subsequent applicant may rely on the undisclosed test or other data submitted in support of an application for marketing approval of new pharmaceutical products for a period of at least six years from the date of marketing approval in China. However, there are reports that generic manufacturers have, in fact, been granted marketing approvals by the China Food and Drug Administration (CFDA) prior to the expiration of this period, and in some cases, even before the originator's product has been approved. The United States was encouraged by China's 2012 JCCT commitment to define "new chemical entity," a term that is central to the application of data protection in the marketing approval process, in a manner consistent with international R&D practice. Given that more than two years have passed since that time, the United States urges China to implement its commitment without delay.
The United States has engaged closely with China to increase efficiency in regulatory approval processes for pharmaceuticals and medical devices to accelerate patient access and incentives to innovate and market new products in China. The United States welcomed China's commitment at the 2014 JCCT to reform its authorization processes and to add personnel and funding. The United States continues to engage with China in support of its reform agenda.
The United States looks forward to continuing to work with China to resolve these and other issues.
INDONESIA
Indonesia remains on the Priority Watch List in 2015. The United States welcomes the new Administration's recent focus on IPR, including with respect to Indonesia's copyright law and trademark legislation. The United States also applauds continued educational outreach to the Indonesian public to advance IPR awareness. Nevertheless, the United States remains concerned about gaps in Indonesia's laws relating to the protection and enforcement of IPR and urges Indonesia to address these issues.
The United States is concerned about rampant piracy and counterfeiting in Indonesia, particularly with respect to the lack of enforcement against dangerous products. In 2014, the
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