On the afternoon of December 11, 2007, the State Food and Drug Administration and the U.S. Department of Health and Human Services signed the Agreement between the Department of Health and Human Services of the United States of America and the State Food and Drug Administration of the People's Republic of China on the Safety of Drugs and Medical Devices at Diaoyutai State Guest House in Beijing, which symbolizes a substantive progress in strengthening cooperation and securing consumer safety of drug use between the two countries.
 
As the biggest developing country and developed country, China and the Unites States are also large producers and consumers of drugs. It is the shared responsibility and topmost target for the governments and relevant departments of both countries to safeguard the basic interests of the consumers in both countries and ensure the safety of drug use. Since July 10, 2007,the State Food and Drug Administration ("SFDA") had set up a core group and a technical group for China-US discussion and conducted in-depth discussions and cross-negotiations with the U.S. Department of Health and Human Services ("HHS") and its subordinated Food and Drug Administration ("FDA"). On October 13, 2007, Commissioner Shao Mingli further communicated with U.S. FDA Commissioner Andrew C. von Eschenbach in Shanghai on the principles of cooperation and some key issues of both parties' concerns. With the active drive by the China-US Strategic Economic Dialogue, both parties, through joint efforts, have strengthened communication, enhanced understanding, reached common knowledge and established platforms and mechanisms for friendly cooperation. The U.S. HHS and FDA have laid great emphasis on the signing of the Agreement, and have taken a proactive attitude towards cooperation. During special meetings of the U.S. Congress on July 16 and October 22, 2007, Secretary of HHS and Commissioner of FDA had respectively given positive comments on the status quo of drug quality and safety in China, the measures taken by Chinese government and drug regulatory authority to ensure drug quality and safety, and the achievements of the discussion.
 
In order to intensify the quality control of drugs and medical devices so as to ensure the safety of drug use by the public in China and the United States, both parties have prioritized the cooperation in import and export control of drugs, including active pharmaceutical ingredients, excipients and finished dosages, and medical devices. Such cooperation would start from the designated products. During the first phase, the Chinese party has designated 8 products while the U.S. party has designated 10 products, and both parties would gradually add to the list of designated products after review and evaluation of the performance, and further expand the areas and channels of cooperation. Besides, both parties will start cooperation in the five following areas:

1. high-level meetings - to establish a meeting mechanism for high-level leaders of drug regulatory authorities of both countries;

2. exchange of information – to exchange information concerning companies subject to respective regulation, and the quality and safety of their products;

3. exchange of legislation – to exchange enaction and revision of laws and regulations;

4. technical cooperation – to exchange technologies of innovative drugs, and to set up a platform for training of inspectors;

5. joint combat against counterfeits – to cooperate in investigating and tracing counterfeited products that might pose threats to consumer health.
 
Strengthening cooperation in drug safety is of great significance for the human well-being, attracting highly attention from the governments and consumers in both countries. Despite of the difference in national realities between China and the U.S., and the fact that the mechanisms and requirements applied for drug administration are not completely the same, those differences would not hinder the friendly intercourse and cooperation between the two countries. The signing of the Agreement is a new starting point of our cooperation. We would improve mutual understanding, reach mutual trust, strengthen cooperation and jointly respond to difficulties and challenges. We also wish to enhance cooperation and exchange with other countries and regions, to jointly maintain the global safety of drugs and medical devices so as to jointly ensure the public health across the world.