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U.S.-China Joint Fact Sheet on the 26th U.S.-China Joint Commission on Commerce and Trade

JCCT OUTCOMES

As recognized by the joint Presidential Economic Fact Sheet issued during President Xi’s State Visit to the United States:  “The United States and China highly value the important role the U.S.-China Joint Commission on Commerce and Trade (JCCT) plays in promoting bilateral economic relations and expanding mutually beneficial cooperation.”  The 26th Annual Joint Commission on Commerce and Trade was successfully held November 21-23, 2015 in Guangzhou. During the JCCT, both China and the United States evaluated the positive and critical role the JCCT has played in the promotion of bilateral economic and trade cooperation; through the co-chairs, the vice ministers and JCCT working groups, the two sides resolved trade and economic issues, expanded mutually beneficial cooperation, and strengthened communication.  During the JCCT, both sides had deep exchanges on topics of concern to each side, and reached the following consensus:

 

 

AGRICULTURAL BIOTECHNOLOGY

China and the United States reaffirm the outcome reached on agricultural innovation in September 2015 at the state visit of President Xi with President Obama.  China and the United States have fully exchanged views about agricultural innovation at the JCCT and the Strategic Agricultural Innovation Dialogue; will jointly promote the cooperation on agricultural innovation; and create a favorable environment for agricultural innovation.  Both sides reaffirmed they would work together to further the approval process based on international standards; and reiterated the importance of adopting a timely, transparent, predictable and science-based approval process.

China and the United States jointly agreed to strengthen policy and information exchange, share the experiences and practices on research and development, supervision and approval; consider domestic and international stakeholders’ comments when modifying and improving regulations.

 

EXPORT CONTROLS

The U.S. Department of Commerce and the Chinese Ministry of Commerce held the 10th meeting of the U.S.-China High Technology and Strategic Trade Working Group (HTWG) in Washington, D.C. on November 10, 2015.  The two sides reviewed the progress made by the working group during the past 10 years, held detailed and in-depth discussion of issues of mutual concern, such as the U.S. export control policy to China, China’s export controls, individual case information exchange mechanism, expansion of priority areas of cooperation, and end use visits. Both sides speak highly of the working group meeting, and further commit to continue detailed and in-depth discussion of the export control issues of mutual interest within the U.S.-China High Technology and Strategic Trade Working Group.

Following President Xi Jinping’s recent state visit to the U.S., both sides agree to actively explore practical applications for potential new priority areas of U.S.-China high technology trade, beginning with the sectors discussed during the visit, for implementation in calendar year 2016.

Both sides agree that in order to further implement the “Action Plan for Cooperation in the Priority Areas of U.S.-China High Technology Trade”, it is important to strengthen the exchange of individual case information to enhance trade confidence, specifically in respect of commercial, high-technology items exported to China for civilian end users and civilian end uses.  Both sides committed to continue to discuss details of the proposed individual case information exchange mechanism and work cooperatively to reach completion soon.

The U.S. side confirms that its amendments on Commerce Control List to implement Wassenaar Arrangement and other multilateral export control regime list revisions result in facilitated exports to most countries, including China, if for civilian end users and civilian end uses. 

The United States reiterated its commitment to encourage and facilitate exports of commercial high technology items to China for civilian end users and for civilian end uses.  The U.S. side agreed to continue to objectively review license applications involving commercial exports to Chinese civilian end users and civilian end-uses consistent with U.S. laws and policies.

The Chinese side identified one individual case of five-axis dual frequency laser interferometer to the U.S. side, and provided additional technical information upon request of the U.S. side.  The U.S. side promised to give timely feedback.

Both sides agreed to continue to strengthen cooperation in end-user visits in accordance with the provisions of the End Use Visit Understanding.

 

COMPETITION

China's anti-monopoly enforcement agencies are to conduct enforcement according to the Anti-Monopoly Law and are to be free from intervention by other agencies.

China clarifies that commercial secrets obtained in the process of Anti-monopoly Law enforcement are protected as required under the Anti-monopoly Law and shall not be disclosed to other agencies or third parties, except with a waiver of confidentiality by the submitting party or under circumstances as defined by law.

Taking into account the pro-competitive effects of intellectual property licensing, China attaches great importance to maintaining coherence in the rules related to IPR in the context of the Anti-monopoly Law.  China clarifies that any State Council Anti-monopoly Commission guidelines will apply to the three anti-monopoly law enforcement agencies.

The Chinese side clarifies that in the process of formulating guidance related to intellectual property rights in the context of anti-monopoly law, it will solicit comments from relevant parties, including the public, in accordance with law and policy.

 

FCC

China expressed its concern that the U.S. Federal Communications Commission No. FCC 14-208 regarding modifications for communications equipment regulations may seriously impact Sino-U.S. bilateral trade in communications products.  The United States is currently considering requests for delay of FCC 14-208.  China and the U.S. will convene a workshop in early 2016, to discuss the implementation of Rule FCC 14-208 and its transition period, the possibility of the establishment of testing accreditation regimes allowing eligible labs in both China and the U.S. to test telecommunication equipment for both countries and to discuss the use of mutual recognition agreements between the United States and other major economies.

 

EXCESS CAPACITY

Steel

The U.S. and Chinese governments and industry representatives agreed to hold discussions in 2016 regarding capacity, production and trade in the steel sector, including updates on progress made with regard to China’s July 2014 U.S.-China Strategic and Economic Dialogue (S&ED) commitment to establish mechanisms that strictly prevent the expansion of crude steelmaking capacity and that are designed to achieve major progress in addressing excess production capacity in the steel sector within five years.  The two sides will exchange information on steel capacity developments in each economy through the JCCT’s U.S.-China Steel Dialogue.

 

Aluminum

The United States and China agreed to intensify their discussions regarding overcapacity in the aluminum sector in 2016.

 

SUPPORTING INVESTMENT IN THE U.S. INFRASTRUCTURE MARKET

Both China and the United States welcome business investment in infrastructure including Public Private Partnership (PPP) projects by domestic and foreign investors.  Both China and the United States recognize the potential for their firms to play a positive role in infrastructure development in both countries and commit to explore opportunities for deepening cooperation in this area. Through the Build America Investment Initiative, the United States has made it an Administration priority to engage with state and local governments and private sector investors to encourage the use of innovative financing, share best practices, and expand the market for PPPs.

 

INFORMATION EXCHANGE ON FISHERIES, TIMBER AND WILDLIFE

The United States and China agree to build on previous JCCT (2014) and S&ED commitments by enhancing information exchange and cooperation, under existing and appropriate agreements and mechanisms, in the areas of IUU fishing, wildlife trafficking, and illegal logging and associated trade.  Recognizing these issues are global in nature, the two countries also agreed to exchange information and cooperate with other trading partners in the region, as appropriate.

 

Cooperation on Fisheries

The United States and China, through the JCCT, S&ED, bilateral fishing exchanges and related bilateral mechanisms and multilateral fora, will expand dialogue and cooperation in the effort to combat IUU fishing.  In order to implement the 25th JCCT outcomes, the two sides will discuss cooperation in fisheries trade statistics and the exchange of relevant information and data.  The two sides agree to hold a discussion in 2016 to continue information sharing and collaboration in support of efforts to combat IUU fishing practices.

 

On the Fight Against Illegal Logging

The United States and China firmly oppose illegal logging and associated trade and seek to implement a cooperative strategy to address these issues.  The two sides agree to continue the fight against illegal logging and associated trade through exchange of information and experiences in the Bilateral Forum on Combatting Illegal Logging and Associated Trade, the S&ED, and other existing bilateral discussions and regional trade fora in 2016.

 

On the Fight Against Wildlife Trafficking

The United States and China attach great importance to combating the global challenge of illegal trade in wildlife and wildlife products.  The two sides agreed to continue to use the S&ED and other existing mechanisms and fora to communicate and cooperate in support of combating wildlife trafficking.

 

RECIPROCAL RECOGNITION OF BILATERAL AIRWORTHINESS ON TRANSPORT CATEGORY AIRPLANES

The Civil Aviation Administration of China (CAAC) and Federal Aviation Administration (FAA) commit to cooperate, further strengthen dialogue and communication, and enhance mutual understanding and trust, to work towards reciprocal recognition of bilateral airworthiness on transport category airplanes for the mutual benefit of the United States and China.

 

FOOD SAFETY

The food safety issue is one of the key issues of global concern.  China and the United States recognize the importance of addressing and resolving food safety issues to protect public health and facilitate trade.  Chinese and U.S. food safety agencies can, through existing food safety cooperation mechanisms, including through the JCCT, further enhance food safety cooperation. China and the United States will, on a scientific basis, engage and cooperate on food safety issues to exchange risk communication and regulatory experiences.  The United States and China reaffirm the importance of participation in the development of international food safety standards, and enhancing transparency in developing and implementing food safety regulations, including releasing draft regulations for solicitation of public comments, and taking into consideration public comments in final food safety regulations. China and the United States will enhance implementation of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), including through efforts to reinforce the use of scientific risk analysis in the development and implementation of food safety measures, strengthen consumer protection, and enhance public confidence in the food supply chain. China and the United States will participate actively in related activities of international organizations in the food safety field, and through exchanges of best practices, with the goal of improving capability to prevent and respond to food safety incidents.

 

EXPORTS OF COOKED POULTRY FROM CHINA TO THE U.S

The United States confirmed that it completed the investigation of China’s slaughter and processing systems for poultry intended for export to the United States.  China requested that the United States begin the regulatory process by the end of 2015.

 

GOVERNMENT SUPPORT

Integrated Circuit (IC) Industry Development Plans

China confirms that the Semiconductor Industry Development Plan policies are equally applicable to and available for foreign-invested enterprises.  For legally binding policies and measures for promoting the semiconductor industry development, China will publish them for public comment according to the procedures and time limits of relevant Chinese laws, and to enhance policy transparency.  China commits that the National Semiconductor Investment Fund will be managed by professional fund companies in a manner consistent with market-based concepts and free from government intervention into normal operational activities.  The United States and China share a commitment to a strong, growing global semiconductor industry that operates under fair, open and transparent legal and regulatory environments.

 

Trade Policy Compliance

China noted that the United States provided comments to the Ministry of Commerce (MOFCOM) concerning the WTO consistency of certain matters relating to International Well Known Brands and farm machinery.  China confirms that MOFCOM will deal with these matters in accordance with the Circular on Strengthening Trade Policy Compliance and the Interim Measures for the Implementation of Trade Policy Compliance.

 

CHANGE OF THE CATFISH IMPORT REGULATOR BY THE U.S.

With a view toward fostering bilateral trade in Siluriformes from China and other countries to the United States, the United States is considering a transitional period for the implementation of a final rule for the regulation of Siluriformes by the U.S. Department of Agriculture.  It will communicate to China regarding the requirements after the final rule is published in the Federal Register.

 

INTELLECTUAL PROPERTY RIGHTS

Standards and Intellectual Property

The United States and China affirm the beneficial role of standards in promoting innovation, efficiency, and public health and safety, and the need to strike an appropriate balance of interests of multiple stakeholders.

The United States and China commit that licensing commitments for patents in voluntary standards are made voluntarily and without government involvement in negotiations over such commitments, except as otherwise provided by legally binding measures.

The United States confirms that Chinese firms participate in the setting of voluntary consensus standards in the United States on a non-discriminatory basis, consistent with the rules and procedures of the relevant standards organizations.  China welcomes U.S.-invested firms in China to participate in the development of national recommendatory and social organization standards in China on a non-discriminatory basis.

With a view to enhance mutual understanding and trust, the United States and China agree to hold dialogues over issues under this topic.

 

Trade Secrets

The United States and China are committed to providing a strong trade secrets protection regime that promotes innovation and encourages fair competition.  China clarifies it is in the process of amending the Anti-Unfair Competition Law; intends to issue model or guiding court cases; and intends to clarify rules on preliminary injunctions, evidence preservation orders and damages. The United States confirms that draft legislation proposed to establish a federal civil cause of action for trade secrets misappropriation has been introduced in relevant committees. Both sides confirm that IP-related investigations, including on trade secrets, are conducted in a prudent and cautious manner.  The United States and China agree to jointly share experiences and practices in the areas of protecting trade secrets from disclosure during investigations and in court proceedings, and identify practices that companies may undertake to protect trade secrets from misappropriation in accordance with respective laws.

 

Geographical Indications (GIs)

The United States and China will continue our dialogue on GIs. Both sides reaffirmed the importance of the 2014 JCCT commitment on GIs and confirmed that this commitment applies to all GIs, including those protected pursuant to international agreements.  China will publish in draft form for public comment, and expects to do so by the end of 2016, procedures that provide the opportunity for a third party to cancel already-granted GIs.

 

Sports Broadcasts

The United States and China agree to protect original recordings of the images, or sound and images, of live events, including sports broadcasts, against acts of unauthorized exploitation, including the unauthorized retransmission of such broadcasts over computer networks, in accordance with their respective laws and regulations.  The United States and China agree to discuss copyright protection for sports broadcasts and further cooperate on this issue in the JCCT IPR Working Group and other appropriate bilateral fora.

 

Enhanced Enforcement Against Media Boxes and Unauthorized Content Providers

Noting the challenges posed by new technologies to the protection of copyright, China and the United States will continue discussions and share respective experiences and practices on combating the unauthorized online distribution of audiovisual content made possible by media boxes.  China clarifies it is to enhance enforcement against such media boxes and the providers of unauthorized content in accordance with its laws and regulations.

 

Online Enforcement

In order to address the civil, administrative and criminal enforcement challenges caused by the rapid development of e-commerce, as part of the JCCT IPR Working Group, China and the United States will enhance engagement and exchanges between U.S. and Chinese government IPR policy and enforcement officials, IP right holders, business representatives and online sales-platform operators, among other relevant stakeholders.  This engagement will cover current and anticipated challenges in protecting and enforcing IPR online by sharing respective practices, discussing possible improvements in each country’s systems, facilitating information exchange and training between our two countries, and increasing cooperation on cross-border enforcement.  The goal of this effort is to enhance existing legal and cooperative regimes among businesses, rights holders and governments in civil, administrative and criminal online IPR enforcement.  Appropriate criminal matters will be referred, if necessary, to law enforcement agencies through the Joint Liaison Group (JLG) IP Criminal Enforcement Working Group or domestic law enforcement officials.

 

PROTECTION OF NEW PLANT VARIETIES

The United States and China agree to hold exchanges on the protection of new plant varieties through bilateral meetings and other means to be determined.

 

COPYRIGHT LEGISLATION

The United States and China are to continue exchanges on the development of their respective copyright laws.  China clarifies that its Copyright Law is in the process of amendment and useful principles and interpretative guidance from the Supreme People Court’s 2012 Judicial Interpretation on Internet Intermediary Liability will be considered in the law, if appropriate and feasible.

 

EXCHANGE ON INTELLECTUAL PROPERTY RIGHTS LEGISLATION

Recognizing the success and experience of recent exchanges on IP legislation through the JCCT IPR Working Group, programs under the Cooperation Framework Agreement and other fora, as well as the desire of the United States and China to further understand recent developments in this area, the United States and China agree to exchange views on their legislative developments in IP and innovation including on pending reforms in copyright law, patent law, trade secret law (anti-unfair competition law), science and technology achievement law, etc., with relevant legislative bodies.

 

BAD FAITH TRADEMARK FILING

Given the importance of addressing bad faith trademark filings, both sides agree to continue to prioritize the issue of bad faith trademark filings, and to strengthen communication and exchange on this issue through existing channels.

 

U.S.-CHINA SUBNATIONAL ECONOMIC TRADE COOPERATION   

To demonstrate the support of the federal and central governments of the two countries for promoting U.S.-China trade and investment cooperation at the subnational level, the U.S. Department of Commerce and the Ministry of Commerce of China entered into a Memorandum of Understanding (“MOU”) to establish a “Framework to Promote Cooperation at the Subnational Level on Trade and Investment between the United States and China” during the 26th Session of the U.S.-China JCCT.  The MOU highlights the priorities that each agency places on facilitating subnational economic, trade, and investment cooperation.

 

PHARMACEUTICALS AND MEDICAL DEVICES

Pharmaceuticals and Medical Devices Registration and Approval

The United States and China affirm:

  • That China publishes annual reports on drugs and medical devices evaluation that include their performance efforts.
     
  • That in 2014 and 2015, China issued clinical trial exemption catalogues for Class II and Class III medical devices and the Medical Device Clinical Trial Evaluation Guidelines, and will conduct relevant training.  In 2016, China will complete the drafting of the second batch of medical device clinical trial exemption catalogues in order to further expand the scope of the exemption catalogues.
     
  • That China is currently refining mechanisms to communicate with registration applicants. For innovative medical devices, the China Food and Drug Administration (CFDA) will appoint dedicated personnel in the evaluation and approval process to provide guidance and promptly communicate with the applicant upon request.  For other types of medical device registration applications, relevant departments of the CFDA will conduct weekly group consultations for applicants.
     
  • That the State Council Opinions on Reforming the Review and Approval Systems for Drugs and Medical Devices (State Council 2015 No. 44) is the guideline for reforming China’s drug and medical device review and approval systems.  China agrees that the CFDA will provide no less than a 30-day public comment period for implementing departmental rules and regulations, and will continue to abide by its technical barriers to trade (TBT) commitments.

 

Medical Devices Localization

In accordance with China’s medical device regulatory legal framework, China agrees that in the area of market access, it will give imported medical devices the same treatment as those manufactured or developed domestically.

 

SPECIAL 301

The United States reiterates its commitment to objectively, fairly, and in good faith evaluate the efforts made by foreign governments, including the Chinese Government, for protecting and enforcing intellectual property rights in the Special 301 Report.  The United States welcomes reforms and actions designed to strengthen China's intellectual property rights protection, and commits to highlight positive actions on IP protection and enforcement undertaken by the Chinese Government in the 2016 Special 301 Report.

 

TECHNICAL REGULATIONS

Cosmetics Regulatory Dialogue

To deepen mutual understanding in cosmetics regulation and promote consumer protection, China and the United States agree to engage and to cooperate under the current JCCT Trade and Investment Working Group framework.  The competent cosmetics regulatory authorities of the two countries agree to consider, through joint seminars and other formats, holding a cosmetics regulatory dialogue to discuss international best practices in cosmetics regulation.  To this end, China and the United States agree to hold, in the first half of 2016, a dialogue in Beijing with participation from the competent U.S. and Chinese regulatory authorities as well as other government officials and stakeholders from the two countries to exchange views on various issues including cosmetics regulations, rules, and regulatory practices.

 

NOTORIOUS MARKETS LIST

The United States reiterates its commitment to objectively, fairly, and in good faith evaluate and recognize the efforts made by and results achieved by foreign entities, including Chinese entities, with respect to intellectual property protection and enforcement in the Notorious Markets List, as appropriate.  The United States intends to pursue steps to enhance the transparency of the process by doubling the length of the rebuttal period for interested stakeholders in 2016.  The United States will continue to hold discussions with China on this matter.

 

TECHNOLOGY POLICY

Pro-competitive and Non-discriminatory ICT Security Policy

The two sides commit that information and communication technology information security measures generally applicable to the commercial sector are not to unnecessarily limit or prevent commercial sales opportunities for foreign suppliers of ICT products, services, or technologies and will not impose nationality-based conditions and restrictions on the purchase, sale and use of ICT by commercial enterprises unnecessarily.

 

Transparency and Clarity of Chinese ICT Security Policy

China confirms that a revised draft of “the banking sector’s guidelines for promotion of the use of safe and controllable information technology (2014-2015)” will be released for a 30-day public comment period and implemented after revision.  Prior to this, China suspended the implementation of these “guidelines” via Notice 57, April 13, 2015.  China is currently soliciting policy revision advice from concerned parties.  Banks in China and the United States, in compliance with laws and regulations, are free to purchase and use the ICT products of their choosing, regardless of the country of origin of such products.

For the “Insurance system informatization regulatory requirements (draft)” China has provided more than a 30-day public comment period.  China will notify the WTO TBT Committee of the “Insurance system informatization regulatory requirements (draft),” and China will formulate this measure in an open and transparent manner.

The Chinese side in March 2000 issued clarifications that encryption products and equipment containing encryption technology included in the scope of “Regulations on Commercial Cryptography Administration” are only limited to software and hardware that, at their core, are dedicated to encryption and decryption operations.

China confirms that it is willing to strengthen exchange and dialogue with the United States on the Multi-level Protection Scheme (MLPS).  

 

EFFECTIVE AND BALANCED PROTECTION OF IPR

While considering TRIPS principles and objectives, the United States and China are to continue communication and exchanges on relevant policies, e.g. helping to protect innovators from bad faith litigation, in order to promote positive conditions for innovation.

 

ADMINISTRATIVE LAW DIALOGUE

The United States and China held a productive joint exchange on administrative law issues in Beijing in April 2015.  The two sides will continue their joint exchange on administrative law issues in Washington, D.C., in Spring 2016 to discuss administrative law topics of interest to our business communities.

 

IP COOPERATION

The United States and China affirm the essential role of IP protection in the US-China bilateral economic and trade relationship.  Acknowledging the benefits of cooperation and recognizing that cooperation forms the underlying basis of bilateral IP exchanges, the US and China commit to further intensify in-depth cooperation in important areas, including:

  • To further the role of the US-China JCCT IPRWG as the leading coordinating bilateral forum for IP issues.
     
  • To continue to attach great importance to the work of the CFA, including judicial exchanges and a training program in China in 2016, and to consider additional programs under the CFA, after completion and review of existing programmatic commitments and subject to budget availability.
     
  • To support a technology licensing joint seminar to be convened by MOFCOM in the first quarter of 2016

Additional programs will be organized on a case-by-case basis.  It is recognized that extensive programming were undertaken by both sides, particularly the US, with a range of agencies and private organizations in IP training and technical exchanges.

 

LEGAL EXCHANGE

The 19th China-United States Legal Exchange was held in Beijing and Wuhan in January 2015.  In a dynamic and fruitful discussion, legal experts from both sides addressed two topics of key concern to both sides:  regulation of air pollution and protection of commercial data.  China and the United States look forward to convening the 20th Legal Exchange in the United States.

 

STRENGTHENING COOPERATION COMBATING INTERNET PIRACY

In order to address suspected instances of online criminal piracy in the United States affecting Chinese right holders, the Joint Liaison Group (JLG) IP Criminal Enforcement Working Group point of contact in the U.S. Beijing Embassy will receive such referrals from China’s administrative agencies.

 

DEEPEN AND STRENGTHEN U.S.-CHINA COOPERATION IN CRIMINAL LAW ENFORCEMENT FOR INTELLECTUAL PROPERTY RIGHTS (IPRS)

Under the working mechanism of Intellectual Property Criminal Enforcement Working Group under the China-U.S. Law Enforcement Joint Liaison Group, China and the United States shall continue to cooperate on transnational IP investigations.  Both sides shall identify priority cases for joint cooperation, maintain regular communication and information-sharing regarding such cases, and explore opportunities for technical exchanges on areas of mutual interest.

 

PROMOTE IPR UTILIZATION AND PROTECTION IN COMPANIES VIA U.S.-CHINA BILATERAL COOPERATION 

Acknowledging the continuous growth of bilateral trade and investment, the U.S. and China agree to enhance cooperation and communication on studies of empirical data related to the protection and utilization of IPR in each other’s territory, and to take specific actions or hold programs in this area that assists U.S. and Chinese policy making to encourage innovation and helps Chinese and U.S. innovators, creators, and entrepreneurs better understand how to create, protect and utilize IPRs in each other’s country.

 

SEARCHABLE DATABASE FOR IP CASES

The United States welcomes that the Supreme People’s Court has established a database for searching intellectual property-related court decisions.  In order to increase the understanding of each other’s legal systems, the United States and China agree to dialogue and to share experiences on their respective databases containing IP cases.

 

VISAS

Both sides agree to continue to exchange views through channels such as the US-China Consular Dialogue on reciprocal arrangements for various types of visas and further facilitate people-to-people exchanges in all fields.

 

LACEY ACT

The United States and China share the objective of combating illegal logging and associated trade and promoting trade in legal wood products.  To that end, the two sides commit to continue to work together through the United States-China Bilateral Forum on Combating Illegal Logging and Associated Trade and the APEC Experts Group on Illegal Logging and Associated Trade.  The two sides will hold the 7th meeting of the Bilateral Forum in 2016, and will endeavor to strengthen communication, information sharing and cooperation on relevant matters, including the implementation of the Lacey Act and the research project on timber legality verification systems, and will seek to encourage the participation of the private sector and civil society in the Bilateral Forum.

 

GENERIC DRUGS

The statutory authority for the United States Generic Drug User Fee Amendments of 2012 (GDUFA) expires at the end of September 2017.  At that time, new legislation will be required for the United States Food and Drug Administration (FDA) to continue to collect generic drug user fees for future fiscal years.  The U.S. FDA affirms that it publicly releases annual reports, including performance and financial, on GDUFA detailing FDA’s efforts to ensure timely review process without compromising the safety and efficacy of the products.  The United States commits that the U.S. FDA, as required by the Federal Food, Drug, and Cosmetic Act, will hold public meetings and conduct discussions with both the generic drug industry and patient and consumer advocacy groups in developing recommendations for the next GDUFA program (FY 2018-2022).  The United States encourages all interested and qualified parties, including relevant Chinese stakeholders, to participate in this process.  This includes industry associations that represent U.S. regulated generic drug companies, as well as patient and consumer advocacy groups representing persons who use U.S.-regulated generic drugs.  The U.S. Department of Commerce and the Office of the U.S. Trade Representative, under the JCCT Medical Devices and Pharmaceuticals Subgroup, will provide information to Chinese stakeholders to facilitate participation in this process.

 

ONLINE COUNTERFEIT DRUG COOPERATION

Combating online sales of counterfeit drugs and keeping citizens safe and healthy is a priority for both China and the United States.  Both countries have previously worked together to combat online sales of counterfeit drugs, and commit to continued collaboration going forward.  This collaboration includes sharing information and best practices on improving public awareness about sales of drugs on the internet, and enhancing communication and coordination in ongoing activities of international organizations.

 

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COLLABORATIVE ACTIVITIES

The 2015 JCCT featured a day of collaborative events that facilitated private sector engagement with public and private sector officials from both the United States and China.   These events focused on important topics including: enhancing corporate governance and transparency; strengthening bilateral cooperation at the state, provincial and local levels; developing mutually beneficial healthcare initiatives; creating partnerships for safe and reliable food chains; and collaborating on issues related to urbanization and smart city development.

 

GOVERNMENT TO GOVERNMENT SIGNINGS

In conjunction with the 2015 JCCT, the United States and China signed: 1) a Memorandum of Understanding with the Chinese Ministry of Commerce to establish a framework to advance cooperation at the subnational level between the U.S. and China; 2) a Memorandum of Understanding establishing an U.S.-China commercial match-making program between the U.S. Department of Commerce International Trade Administration and the China Council for the Promotion of International Trade (CCPIT); 3) a work plan between the U.S. Department of Commerce, Office of the U.S. Trade Representative, and Chinese Ministry of Commerce on the Foreign Direct Investment Statistics for United States – China Statistics Working Group; and 4) a Framework Agreement with the U.S. Trade and Development Agency (USTDA) and Chinese Ministry of Commerce extending cooperation between USTDA and MOFCOM for an additional five years.