Contents

3.4 - INTERNATIONAL AGREEMENTS

3.4.1 - Memoranda of Understanding

The Agency has over the years entered into agreements with foreign governments regarding the quality of foods, drugs, and other products exported to the United States. The complete text of the agreements is in the International Cooperative Agreements Manual.  The listing is by country and CPG order.  Refer to FDA's website at http://www.fda.gov/oia/default.htm for additional information.

3.4.2 - MUTUAL RECOGNITION AGREEMENTS

3.4.2.1 - European Community

Changes in FDAMA have required that FDA begin the process of acceptance of mutual recognition agreements relating to the regulation of FDA regulated commodities, facilitate commerce in devices between the US and foreign countries and other activities to reduce the burden of regulation and to harmonize regulatory requirements. See Section 803. Additional specific information is available at http: //www.fda.gov/oia/homepage.htm.

3.4.2.2 - Pharmaceuticals and Medical Devices

The first mutual recognition agreement (MRA) to be implemented, The Joint Declaration to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA) was signed in May 1998. It consists of the following sections:

1. Framework
2. Telecommunication Equipment
3. Electromagnetic Compatibility (EMC)
4. Electrical Safety
5. Recreational Craft
6. Pharmaceutical Good Manufacturing Practices (GMPs)
7. Medical Devices

It covers both FDA regulated and non-FDA regulated products and is an agreement between the United States and the European Union (EU) representing 15 Member States. It establishes procedures leading to FDA acceptance of inspectional work done by (EU) Regulatory or Competent Authorities (RA/CA) or Notified Bodies termed Conformity Assessment Bodies (CABs) in the MRA. The pharmaceutical annex is based on an assessment of equivalence with the Member States and the medical device annex is based on inspections by non-government firms who are recognized by the Member State regulatory authority. FDA has begun the process of implementing this agreement which has a 3 year transition period before the operational phase.

3.4.2.3 - Food Products

In July, 1999, the United States and the EC signed the "AGREEMENT BETWEEN THE UNITES STATES OF AMERICA AND THE EUROPEAN COMMUNITY ON SANITARY MEASURES TO PROTECT PUBLIC AND ANIMAL HEALTH IN TRADE IN LIVE ANIMALS AND ANIMAL PRODUCTS". This agreement is very much like a mutual recognition agreement and is based on the equivalence process. It covers a very wide range of human food products, all of animal origin, such as milk and dairy products, seafood, honey, wild game, snails, frog legs and canned pet food. For purposes of this agreement, the EC is considered one "party" and not 15 Member States. Activities to begin assessing equivalence are underway.

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