Agreement Between FDA and China

FDA - SFDA

Agreement between
the Department of Health and Human Services
of the United States of America
and the State Food and Drug Administration
of the People's Republic of China on
the Safety of Drugs and Medical Devices

The Department of Health and Human Services (“HHS”) of the United States of America ("United States") and the State Food and Drug Administration ("SFDA") of the People’s Republic of China ("China") (hereinafter referred to together as "the Parties"):

Understanding the mutual benefits of protecting the public health through improved cooperation between the Parties with regard to monitoring and regulating the safety of drugs and medical devices;

Desiring to work together to better ensure the safety and quality of Drugs, Excipients, and Medical Devices; and

Recognizing that such cooperation can improve the health of the citizens of both the United States and China and enhance confidence in the regulation of Drugs, Excipients, and Medical Devices in both countries;

Have agreed as follows:

Article I    Purpose

The purpose of this Agreement is to establish methods of cooperation between the Parties that will provide the Food and Drug Administration within HHS (“HHS/FDA”) with additional information about products exported from the customs territory of China to the United States, provide SFDA with increased sharing of information about products exported from the United States to China, and encourage further regulatory cooperation between the Parties regarding Drug and Medical Device regulation.

Article II    General Principles

1. The Parties shall engage in regulatory cooperation regarding the export of Drugs, Excipients, and Medical Devices from the customs territory of China to the United States and Drugs, Excipients, and Medical Devices produced in the United States and exported to the customs territory of China as set out in Article VI and as further defined in Work Plans to be agreed upon by the Parties.
2. The Parties shall engage in information-sharing to improve their mutual understanding of, and to gain greater confidence in, each Party’s regulatory system as set out in Article V and as further defined in Work Plans to be agreed upon by  the Parties.  As specified in Article V, each Party shall share relevant information with the other Party, including on relevant laws, regulations, areas of jurisdiction, and public health and safety.
3. The Parties shall engage in regulatory cooperation regarding improving the authenticity, quality, safety, and effectiveness of Drugs, Excipients, and Medical Devices as set out in Articles IV and VI and as further defined in Work Plans to be agreed upon by the Parties. 

The Parties shall commit to annual meetings between senior Agency leaders to discuss and evaluate progress under this Agreement, among other things.

For purposes of this Agreement the following definitions shall apply:

1. "API" or "Active Pharmaceutical Ingredient" means any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product.  Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.  
2. "Counterfeit Drugs and Medical Devices" means a product that is deliberately and fraudulently mislabeled with respect to identity and/or source.  Counterfeiting can apply to branded and generic products and may include products with correct ingredients, with wrong ingredients, without active ingredients, with incorrect quantity of active ingredient, or with fake packaging.
3. "Designated Drugs and Designated Medical Devices" means a Drug (including APIs) and Excipients or Medical Device, respectively, designated for inclusion in each phase of implementation, based on criteria established in Article IV. A.
4. "Drug" means any material commonly used for human pharmaceutical use.  The term includes the following materials:
   1. Finished-dosage forms (including both over-the-counter ("OTC") and prescription drugs);
   2. Drug substance, or active pharmaceutical ingredients ("APIs");
   3. Biologic drugs (e.g., vaccines and monoclonal antibodies); and
   4. Products taken by mouth intended to supplement the diet that:
      1. bear or  contain one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use in humans to supplement the diet by increasing the total dietary intake; ora concentrate, metabolite, constituent, extract or combination of any of the above; and
      2. meet any one of the following characteristics:
             - are not clearly labeled as dietary supplements; or
             - contain claims to diagnose, cure, mitigate, treat, or prevent disease; or
             - contain substances that are regulated by HHS/FDA as APIs.

To read the rest of the agreement, click here.