China to Evaluate Eight Pending Biotechnology Product Applications

In a joint statement, President Donald Trump and President of the People’s Republic of China Xi Jinping announced a 100-day action plan under the framework of the U.S.-China Comprehensive Economic Dialogue — a result of the meeting at Mar-a-Lago, writes Julie Deering on

According to the U.S. Department of Commerce, approximately one month after the Presidential Summit, the two sides reached consensus on addressing issues in the areas of agricultural trade, financial services, investment and energy. In addition, both sides also identified issues that will require significant effort to resolve beyond the 100-day action plan, of which both sides further committed to strengthen communication and coordination to advance those issue.

The action plan focuses on 10 commitments, one of which is for China’s National Biosafety Committee (NBC) to meet by the end of May 2017 to conduct science-based evaluations of all eight pending U.S. biotechnology product applications to assess the safety of the products for their intended use.

No additional information unrelated to the safety assessment for intended use is to be requested of the applicants, according to the joint commitment. For any product that does not pass the safety evaluation at the NBC meeting, the NBC is to operate with transparency by providing in writing to the applicants a complete list of requested‎ information necessary to finalize the safety assessment for the products’ intended use, along with an explanation of how the requested information would be relevant to the safety of the products’ intended use.

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