CHINA OFFICE

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 Offices 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;
• Conducting risk-based, commodity-specific inspections to meet the requirements of FDA’s legislative mandates; and
• 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.

Contact Information:

Recent Release

FSMA's Produce Safety Rule Now Available in Chinese, Portuguese and Spanish

March 10, 2021

The FDA is pleased to announce that the Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) is now available in Chinese and Portuguese. The PSR was previously translated into Spanish.

Adding Chinese and Portuguese translations of the PSR helps to ensure that this important produce safety regulation is accessible to a broad audience.

In conjunction, the Produce Safety Alliance, an FDA-funded produce safety training partner, is publishing a grower curriculum for farmers in Chinese and will soon finalize the curricula in Portuguese.

The translations of the PSR can be found on the FSMA Web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-produce-safety.

Additional information:

PSA Grower Curricula in Chinese
 

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.

• FDA's Global Efforts to Protect Patients and Consumers from Unsafe Products
• FDA's Global Efforts to Protect Patients and Consumers from Unsafe Products - CHINESE VERSION

Online Resources for FDA Regulated Products

• Biologics
  • Foreign Regulatory Seminar (Web-Based): CBERs Regulation of Biologics (Chinese Scripts)
• Cosmetics - Chinese
• Devices
  • An Introduction to FDA’s Regulation of Medical Devices (Chinese)
  • Medical Device Webinars and Stakeholder Calls
• Drugs
  • CDER Small Business and Industry Assistance
  • SBIA Resources in Chinese
• Radiological Health – Electronic Product Certification and Quality Control Testing Programs (Chinese)
• Radiological Health – How to Get Your Electronic Product on the U.S. Market (Chinese)
• Food
  • New Era of Smarter Food Safety
  • New Era of Smarter Food Safety Blueprint (Chinese)
  • FSMA Final Rule on Produce Safety
  • FSMA Final Rule on Produce Safety (Chinese)
  • Importing Food Products into the United States
    • FDA’s Imported Food Safety Strategy
    • Overview and Background of Prior Notice of Imported Foods
  • Biennial Registration and DUNS guidance
    • Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period | FDA
    • FDA Reminds Human and Animal Food Facilities About This Year’s Biennial Registration Renewal Period and Provides Updated Guidance on How to Obtain and Submit a DUNS Number | FDA
    • Food Facility Biennial Registration Renewal Fact Sheet | FDA
    • Food Facility Registration User Guide: Biennial Registration Renewal FDA
    • Foreign Food Facility Inspection Program Questions & Answers (Chinese version)

International Arrangements

• MOU between FDA, HHS and Certification and Accreditation Administration of the People's Republic of China Regarding Registration of U.S. Food Manufacturers Exporting to China (June 2017)
• Implementing Arrangement with CFDA (November 2014)
• Implementing Arrangement with AQSIQ (November 2014)
• MOU between U.S. FDA and China's Center for Food Safety Risk Assessment (December 2013)
• FDA - SFDA China, Agreement on the Safety of Drugs and Medical Devices (December 2007)
• FDA - AQSIQ China, Agreement on the Safety of Food and Feed (December 2007)

Resources For You

• Contact Information: OGPS Offices
• Countries and Regions Covered by OGPS Offices
• FDA Globalization 
• From a Global Perspective
• Imports and Exports 
• International Arrangements 
• News, Speeches and Publications 
• Partnerships and Collaboration 
• President's Emergency Plan for AIDS Relief (PEPFAR)