U.S Secretary of Commerce Penny Pritzker and U.S. Trade Representative Michael Froman hosted the U.S-China 25th the Joint Commission on Commerce and Trade (JCCT) meeting held December 16-18 in Chicago.
The JCCT meeting is the primary forum for addressing lateral trade and investment issues and to discuss ways to promote commercial opportunities between the U.S. and China. High level plenary meetings are held annually and co-chaired by the U.S. Secretary of Commerce, the U.S. Trade Representative, and the Chinese Vice premier in charge of trade and investment issues.
The Fact Sheet on the JCCT meeting released December 19th, reports that exports of U.S pharmaceutical products to China is the second largest export market for pharmaceuticals in the world. China and the U.S agree that the time-to-market for both innovative pharmaceutical products and medical devices should be reduced to allow for better patient outcomes and more exports to China.
The U.S and China reached consensus at the JCCT meeting on several issues:
- China will push forward reform of the medical device and pharmaceutical regulatory review and approval system and will make great efforts to eliminate the drug application backlog within 2-3 years
- Applicants can use Multi-Regional Clinical Trial data including data from China in order to apply for clinical trial waivers. If applications comply with technical review requirements, then applicants can receive clinical trial waivers in China to prevent duplicative testing
- China will implement measures to allow drugs not marketed in foreign countries to conduct clinical trials in China and at the same time, conduct clinical trials in another country. Applicants will be able to submit evidence of marketing approval of a pharmaceutical product in another country when applying for the drug license after completing clinical trials
- China and the U.S agree that all draft pharmaceutical and medical device rules and regulations where notifications are required under WTO rules, will include a comment period for no less than 60 days
China and the U.S agree to engage in dialogue with expert and high level officials from relevant Chinese and U.S. agencies in 2015 to promote efficient pharmaceutical and medical device regulation and market access.
Other topics discussed at the JCCT meeting included agricultural biotechnology, technology localization, intellectual property rights, and treatment for intellectual property in standards setting.
Go to www.commerce.gov/news/fact-sheets/2014/12/19/fact-sheet-25th-us-china-joint-commission-commerce-and-trade for the “Fact Sheet: 25th U.S-China Joint Commission on Commerce and Trade”, or call 202-482-4883.