Actions Requested of The People's Republic of China by The U.S. Government to Address The Safety of Drugs

On May 22-24, 2007 representatives of the United States Government met with representatives of the Government of the People's Republic of China to request rapid action to accomplish goals related to pharmaceuticals, as outlined below.  U.S. representatives presented this request during several bilateral sessions conducted in conjunction with the second, cabinet-level meeting under the U.S.-China Strategic Economic Dialogue (SED) in Washington D.C.

The U.S. has requested the following:

• Registration in China of firms that export products to the United States with the Chinese Government, and prohibition of the export to the United States of products from unregistered firms.
  • A list of these registered firms, semiannual updates, and verification of the registration status of other Chinese firms identified by the Food and Drug Administration (FDA) of the US Department of Health and Human Services (HHS) that appear to have engaged in the export of products to the United States.
  • Periodic systems audits by HHS/FDA officials to confirm, as needed, the effectiveness of the registration program.
  • Inspection in China of the registered firms, periodically as well as at the request of HHS/FDA if specific issues regarding safety of the product arise.
  • Notification of FDA when the Chinese government removes any firm from the list of registered firms authorized to export to the United States.
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• That the Chinese State Food and Drug Administration (SFDA) mandate that all chemical manufacturers that produce Active Pharmaceutical Ingredients (API) register with SFDA and face SFDA inspection and regulation to ensure compliance with US requirements.

• That SFDA will increase its cooperative activities with the Chinese Ministry of Public Security and Customs to investigate actively investigate and criminally prosecute violators that illegally manufacture, sell, or export bulk API.

• That SFDA will act promptly on requests from the U.S. government or U.S. industry to investigate suspected illegal activities and immediately prosecute violators.

• That SFDA will co-host with the HHS/FDA a U.S.-China government dialogue, co-chaired at the Vice Minister/Under Secretary level, before August 31, 2007, on the issue of the health and safety of the pharmaceutical drug-supply chain, and endeavor to obtain the participation of all relevant minisries agencies, including the Ministry of Public Security, Customs, the General Administration for Quality, Safety Inspection and Quarantine, and the Ministry of Health.

• That China will adopt and maintain WHO-consistent health and safety practices and guidelines, consistent with the World Health Organization (WHO) standards, including the enforcement of laws and regulations that encompass APIS and finished dosage forms that are misidentified as to source and composition.

• That China will participate actively in the WHO’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT).

• That China will investigate the recent reports of diethylene glycol in toothpaste exported from China.