New Agreement Will Enhance the Safety of Drugs and Medical Devices Imported From the People’s Republic of China

On Dec. 11, 2007, the U.S. Department of Health and Human Services (HHS) and the State Food and Drug Administration (SFDA) of the People’s Republic of China signed a Memorandum of Agreement (MOA) to enhance the safety of drugs, excipients and medical devices exported to the U.S. from China.  The agreement was signed in Beijing by HHS Secretary Mike Leavitt and SFDA Commissioner Shao Mingli in advance of the third session under the United States-China Strategic Economic Dialogue.   

Specifically, the two countries are establishing a bilateral mechanism to help ensure these imported products meet standards for safety and effectiveness by building quality into the process from the start.  SFDA will require firms that manufacture certain products intended for export to the United States to register with SFDA.  SFDA will also work toward a system that will enable it to certify that firms that manufacture products, and the products themselves, meet HHS/Food and Drug Administration (FDA) requirements. 

The agreement covers the following drugs and medical devices that are manufactured in China for export to the United States: gentamicin sulfate (an antibiotic), atorvastatin (a cholesterol-lowering drug), sildenafil (a drug for erectile dysfunction), dietary supplements intended for erectile dysfunction, human growth hormone, oseltamivir (an antiviral product), cephalosporins (a class of antibiotics) manufactured in facilities that also manufacture non-cephalosporin drugs, glycerin, glucose test strips, and condoms.

Key Terms of the Agreement

New Registration and Certification Requirements.  All Chinese producers of these drugs and devices are required to register with the Chinese government, and the two countries will work together to develop and implement a program to certify that those items exported to the United States meet HHS/FDA safety standards.

To support these registration and certification programs, the two countries will conduct joint training programs and activities to cover topics such as inspection methods, clinical trials to ensure safety and the development of technical guidance documents, laws and regulations.

Greater Information-Sharing.  HHS/FDA and SFDA will exchange information on drugs and devices to better ensure product safety.  For example, SFDA will notify HHS/FDA within 24 hours of any determination that a product sent to the United States could cause serious adverse health consequences, and also provide the tracking information necessary to identify the shipment and supplier.  In the past, there was no formal system of notification between regulators in the two countries. 

Within the first 30 days, HHS/FDA and SFDA will exchange lists of registered firms that manufacture certain drugs and medical devices in each country.  SFDA will also provide to HHS/FDA a list of manufacturers that have been determined to be out of compliance with SFDA requirements, and access, upon request, to records concerning reviews, inspections, testing, recalls, compliance or other testing and verification methods.  SFDA will also share with HHS/FDA copies of all current Chinese regulations that cover drugs and medical products. 

Increased Access to Production Facilities.  SFDA will assist and facilitate HHS/FDA access to relevant manufacturing sites in China.

Stronger Product Integrity and Security.  To guard against counterfeiting, HHS/FDA and SFDA will collaborate to establish a comprehensive electronic tracking system that applies to certain drugs at risk for counterfeiting, and enhance enforcement against producers that fail to provide tracking information.  Both sides will report counterfeit drugs they identify to the World Health Organization (WHO).  The two sides will develop a separate program to inform and educate supply-chain stakeholders and the public on how to avoid misbranded, adulterated or counterfeit drugs and medical devices, and how to report any they do encounter.

Implementation and Establishing Key Benchmarks.  SFDA and HHS/FDA will create a Working Group, which will meet within 120 days to develop a plan, to be posted online, for implementing the agreement and setting performance measures to evaluate progress.  To do so, HHS/FDA will look to rely on benchmarks such as the rate at which it refuses entry of covered products to the United States; and the volume, frequency and public-health significance of products recalled, including counterfeit goods, as compared to the previous year.  Senior health officials from the two countries will meet annually to discuss and review progress on the Agreement. 

Encouraging China’s Involvement in International Regulatory and Public-Health Bodies. With support from HHS/FDA, SFDA will implement regulations and practices consistent with those established by the WHO.  It will report counterfeit drugs to the WHO Secretariat and will actively participate in the organization’s anti-counterfeiting task force and forum on international pharmaceutical crime.  HHS/FDA will also help SFDA better understand the importance of actively reporting to the National Competent Authority Reporting program any serious adverse events that involve medical devices.  This program operates through the Global Harmonization Task Force, which works to eliminate differences in the international regulation of medical devices.  

Background

In July, President Bush appointed Secretary Leavitt to chair a Cabinet-level Working Group on Import Safety, made up of twelve Federal Departments and agencies.  Members of the Working Group visited ports, border crossings, supermarkets, retailers, meat and seafood processing facilities, and wholesalers across the United States to gain a better understanding of the vast import process.  Secretary Leavitt also met with his counterparts from G-7 nations, Mexico, and the European Commission to discuss common import-safety challenges.  On Nov. 6, 2007, the Working Group presented an Action Plan to the President made up of short- and long-term recommendations to bolster the safety of the increasing volume of imports that are entering the United States.  

The MOA complements the vision and goals outlined in the Action Plan, and will serve to build on efforts already underway by the U.S. Government to enhance the safety of imported products.

During the second session of the United States-China Strategic Economic Dialogue in May 2007, HHS/FDA and SFDA launched negotiations on a binding MOA on the safety of drugs and medical devices exported from China to the United States.  The negotiations resulted from a growing concern over ensuring the safety, quality, and effectiveness of many Chinese products exported to the United States.

Over the course of four sets of talks from July to November 2007, senior officials from HHS/FDA engaged in negotiations with senior officials from a number of agencies in the Chinese Government.  The negotiations began with a vision to increase cooperation and information-sharing between the United States and Chinese Governments on the safety of exported drugs and medical devices, and, at the request of the Chinese, to enhance the technical capacity of China’s regulatory agencies to help ensure Chinese exports to the United States meet U.S. safety standards.  

Secretary Leavitt also signed a Memorandum of Agreement with the Chinese General Administration for Quality Supervision, Inspection and Quarantine to enhance the safety of food and feed exported from China to the United States.

Drugs and Medical Devices Agreement>>