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Established in November 2008, the Office of Global Policy and Strategy's (OGPS) China Office serves as the lead for the FDA’s on-site presence in China. The mission of the Beijing-based office is to help ensure the safety, quality, and effectiveness of medical products and food produced in China for export to the United States.

The China Office seeks to accomplish these objectives by:

  • Promoting international health policy harmonization and regulatory convergence
  • Engaging with regulatory authorities, industry, academia, multilateral organizations, non-governmental organizations, and other relevant institutions to increase the FDA’s understanding of China’s regulatory framework and processes and share information about FDA’s science-based regulations and requirements
  • Monitoring and reporting on regulatory trends, conditions, and emerging public health events that have the potential to impact the safety of FDA-regulated goods produced in China intended for U.S. consumption
  • Expanding upon and building better quality data to inform the FDA's regulatory decisions and actions
  • Conducting risk-based, commodity-specific inspections to meet the requirements of FDA’s legislative mandates and
  • Supporting the U.S. Embassy, Beijing, to ensure the coordination of U.S. government activities that are related to FDA equities.

Contact Information:

Celia Gabrel, Acting Director
China Office
Office of Global Policy and Strategy
U.S. Food and Drug Administration
U.S. Embassy

Tel: +86-10-8531-3000
Fax: +86-10-8531-3131
E-mail: US-FDA-CNO@fda.hhs.gov

Focus on China

China ranks third among countries that export drugs and biologics to the United States. China also ranks first among countries that import devices to the U.S. The top three medical device imports from China are surgical drapes, non-absorbable gauze and surgical gowns.

Drugs and medical devices are overseen by the former China Food and Drug Administration (CFDA) now the National Medical Products Administration (NMPA), which reports to the State Administration of Market Regulation (SAMR). NMPA is responsible for conducting drug registration and approvals, provides guidance to provincial authorities and works with provincial level investigators to assign inspections of clinical trial facilities and international inspections.

Imported and exported food are regulated by the former General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), now the General Administration of Customs, China (GACC). GACC is also responsible for registering companies that export. Registration includes annual inspections to ensure that registered companies exporting regulated products to the United States are compliant with U.S. requirements.

Online Resources for FDA Regulated Products

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