PrintOn October 28-29, 2009, high-ranking officials from both China and the U.S. met in California to discuss important issues, such as medical product importation regulations and local testing requirements. The 20th U.S. - China Joint Commission on Commerce and Trade (JCCT) included Chinese Vice Premier Wang Qishan, U.S. Commerce Secretary Gary Locke, and U.S. Trade Representative Ron Kirk.
On the medical device front, China plans to develop product recall regulations that are not redundant or duplicative. In addition, the State Food and Drug Administration (SFDA) and Ministry of Health will be the responsible organizations for medical device recalls. China will also allow a prior medical device registration from a foreign country regardless of the medical device’s exporting origin, country of manufacture or legal manufacture.
Conducting medical device testing locally in China has also been a main point of concern. China is considering accepting data from clinical trials conducted outside of China during product registration instead of requiring local trials in China. Other proposals include exempting sample testing in China test labs prior to approval if the manufacturer demonstrates compliance with international standards. China will also strive to implement regulations, rules and notices that are consistent with medical device guidance documents issued by the Global Harmonization Task Force and the Asia Harmonization Working Party.
On the pharmaceuticals front, China is planning to establish a Drug Master File system. To increase its oversight of active pharmaceutical ingredients (APIs) and counterfeit drugs, China also plans to enforce record-keeping requirements for API manufacturers and sellers. The SFDA will be the main point of contact for the Interagency Coordination Conference for Fighting the Production and Sales of Counterfeit Drugs. In addition, this Interagency Coordination Conference will share information with the U.S. Food and Drugs Administration.