China has agreed to streamline its regulatory processes and cut red tape for imports of new drugs, a move that should benefit the U.S. pharmaceutical industry, the U.S. Commerce Department says.
U.S. officials made the announcement at the conclusion of discussions during the U.S.-China Joint Commission on Commerce and Trade (JCCT) in Chicago.
Under the agreement, China will accelerate reform of its regulatory review and approval system, including eliminating its drug approval backlog within two to three years.
The U.S. and Chinese governments agreed that excessively long timelines for getting innovative drugs to market in China is problematic for companies and deprives Chinese patients of important healthcare options and benefits, the U.S.-China Business Council (USCBC) told its members following the event.
China will implement measures that allow experimental drugs be tested in China while they are being tested in other countries, which will help shorten a drug’s time to market in China, USCBC said. In addition, applicants who use multi-regional clinical trial data that includes data from China can receive clinical trial waivers, provided that their applications comply with technical review requirements.
Progress achieved during the JCCT will benefit the drug industry and many other sectors that support good-paying jobs across the economy, said U.S. Trade Representative Michael Froman.
The U.S. drug industry directly employs more than 810,000 workers and supports a total of 3.4 million jobs in the U.S., while annual exports of U.S. drug products to China have exceeded $1.2 billion, according to figures provided by the Commerce Department.
Learn the ins and outs of Chinese drug import laws and regulations with China Pharmaceutical Guidebook.