China and U.S. Discuss Medical Device and Pharmaceutical Changes

On September 16, 2008, high-ranking officials from both China and the U.S. met in California to discuss important issues, such as medical product importation regulations and intellectual property rights. The 19th U.S. – China Joint Commission on Commerce and Trade (JCCT) included Chinese Vice Premier Wang Qishan, U.S. Commerce Secretary Carlos Gutierrez, and U.S. Trade Representative Susan Schwab.

On the medical device front, China has recently proposed a new pricing policy, but under the recent draft, Chinese consumers would have limited access to high-quality imported medical devices. The Chinese National Development Reform Commission (NDRC), however, has agreed to consult with the U.S. government and key stakeholders upon revision of this policy.

The two governments have also begun discussions regarding China’s government purchasing policies. China has agreed to discuss its government purchasing process with the U.S. government and key stakeholders. All parties hope to ensure that there is a fair process and due consideration for the innovation and quality of medical devices.

Additionally, China’s State Food and Drug Administration (SFDA) and Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) announced a simplification of the registration process so that medical devices need only go through one registration for both administrations.

On the pharmaceuticals front, China has announced that it will update its National Essential Drug List and regional reimbursement drug lists biennially (every 2 years), according to its domestic regulations. Also, China and the U.S. both agreed to continue the effort to reduce drug counterfeiting. Under the agreement, they would continue cooperation to reduce legal loopholes that allow chemicals to be sold in bulk to wholesalers or retailers of counterfeit drugs.

The two governments also discussed intellectual property rights, including China’s proposed patent law amendments and pharmaceutical data protection.