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November 8, 2000                        
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THE FIFTH INTERNATIONAL CONFERENCE ON HARMONISATION

On November 9, 2000, Dr. Jane Henney, Commissioner of Food and Drugs will speak on "Science-Based Regulatory and International Cooperation" at the 5th International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceutical for Human at the San Diego Marriott.

The purpose of the ICH meetings is to bring together the regulatory authorities of Japan, the European Union, and the United States to meet with experts from the pharmaceutical industry to develop guidelines for the global development and availability of new medicines by establishing international quality, efficacy, and safety standards.

This work will help make new drugs and biologics available with minimum delays not only to American consumers but also to patients in other parts of the world by minimizing duplicate testing during the research and development of new drugs. The ICH process results in guidance documents that promote international consistency in the requirements for product approval.

Given the increase in imports, FDA is continually seeking ways to enhance the efficiency and effectiveness of its international inspection, technical cooperation, and harmonization efforts.

This dramatic rise in imports of FDA-regulated products into the United States, and the rapid increase in the development of products and process standards by international and other organizations, have helped to focus the agency's attention on its international role. FDA can better fulfill its mandate to protect and promote the public health by collaborating and cooperating with its foreign regulatory counterparts and international standards-setting organizations.

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