Protecting Innovation and Promoting Trade in Safe Food and Drugs

Building on successful discussions during the 2012 US-China High-Level Agricultural Symposium, the July 2013 S&ED, and looking towards a productive and mutually beneficial December 2013 meeting of the Joint Commission on Commerce and Trade (JCCT), the United States and China affirm the importance of deepening cooperation to address a range of food and drug issues of common concern. Availability of high-quality and safe food and drugs are essential to the growth of our economies and well-being of our peoples. The United States and China therefore commit to the following measures related to promoting and protecting innovation, as well as ensuring safe and well-regulated bilateral trade in food and pharmaceuticals.

The United States and China commit to carry out communication and cooperation on agro-chemical regulation, standards for testing methods and drug and pesticide residue limits and regulation on edible agricultural products for import and export.

In line with the reform goals of the Third Plenary Session of the 18th CPC Central Committee, China commits to promote the reform of its regulatory system for active pharmaceutical ingredients (APIs) by implementing Drug Master File (DMF) management for APIs and to study the possibility of setting up a framework for the registration of bulk chemicals that can be used as APIs. The two sides mutually affirm the central role of drug manufacturers in ensuring drug quality, and will exercise appropriate regulatory oversight over manufacturers towards this end. The US Food and Drug Administration commits to review its authorities to determine whether it can exclude from consideration for import APIs from Chinese firms that are not registered with the China Food and Drug Administration.

China affirms that the Chinese Patent Examination Guidelines permit patent applicants to file additional data after filing their patent applications, and that the Guidelines are subject to Article 84 of the Law on Legislation, to ensure that pharmaceutical inventions receive patent protection. China affirms that this interpretation is currently in effect.

To promote bilateral communication and cooperation in pharmaceuticals, medical products and food safety, the Chinese side commits to issuing visas for US Food and Drug Administration (FDA) food inspectors, drug inspectors and food expert referenced in Diplomatic Note 1252 of November 19, 2012 and Diplomatic Note 0843 of August 20, 2013. These personnel will be posted to the US Embassy in China, with diplomatic privileges and immunities. At the same time, the United States commits that, on a reciprocal basis, China increases its relevant staff in the Chinese Embassy in the United States, with diplomatic privileges and immunities. No later than January 17, 2014, the two sides commit to signing an memorandum of understanding to specify the scope of activity of these personnel.

The United States and China commit to discuss issues concerning China raised in the Consolidated and Further Continuing Appropriation Act, 2013.

The United States and China recognize the importance of promoting non-discriminatory government procurement policies. The two sides commit to have further consultation on China's concerns regarding non-discriminatory treatment of Chinese-invested enterprises established in the United States in US government procurement.