Advances in Biopharmaceutical Technology in China
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Chapter 9:   FDA Requirements Applicable to Testing and Manufacturing Pharmaceutical Products in China for the U. S. Market

Donald Beers and Haifeng Xue
Arnold & Porter, LLP
555 Twelfth Street, NW
Washington, DC 20004-1206

About the Author:
Donald O. Beers is Partner at the Washington, DC Office of Arnold Porter. His areas of expertise include: Biotech and medical technology, and healthcare and pharmaceutical compliance. Mr Beers is experienced in both litigation and regulatory matters involving human and veterinary drugs, and medical devices. He has counseled FDA-regulated companies and represented them before the Agency, in the Congress and in the courts, on a wide variety of FDA-regulatory and related issues. Mr. Beers served the Food and Drug Administration for over ten years as Associate Chief Counsel for Drugs, Associate Chief Counsel for Enforcement, and attorney in the Office of Chief Counsel. He also clerked for the Honorable Milton Pollack of the United States District Court, Southern District of New York. Mr. Beers is the author of Generic And Innovator Drugs: A Guide to FDA Approval Requirements (Aspen Law and Business, 6th ed. 2004), the Web site guide, "Regulatory Considerations in Development of a Biotechnology Product for Therapeutic or Diagnostic Use," and articles on regulatory issues. He taught food, drug, and medical device law as an adjunct professor at the University of Pennsylvania Law School in 1982-1984. Admitted: District of Columbia, Supreme Court of the United States. Published Articles include Follow-on Biological Products: The Regulatory Minefield, Global Counsel Life Sciences Handbook, and Legal and Scientific Considerations in Nonclinical Assessment of Biotechnology Products, Drug Information Journal. Education: J.D., Columbia Law School, 1974, B.A., Dartmouth College, 1971.
Haifeng Xue, Ph.D. is an Associate, Washington, DC Office of Arnold Porter. Areas of Expertise include IP/ Technology, litigation, and life sciences. Scope of Practice: Negotiates agreements with IP components, including license agreements, nondisclosure and confidentiality agreements, research and development agreements, and other related service agreements. Participates in corporate, securities, product liability, and patent litigations. Admitted: District of Columbia, New York, U.S. Patent and Trademark Office. Education: J.D., Columbia University Law School, Harlan Fiske Stone Scholar, 2004, Ph.D., Columbia University, 1999, B.S., Fudan University, 1990

Testing pharmaceutical products in China for the U. S. market has apparent appeal. One obvious aspect is the cost: a large number of skilled scientists/medical professionals and a large patient pool, both inexpensive relative to those in the U.S., make testing pharmaceutical products in China attractive. China is relatively easy to recruit investigators and patients It is also thought that there is a more permissive climate for animal testing. Manufacturing pharmaceutical products in China for the U.S. market also seems appealing, again mainly due to the low cost. Novartis, Pfizer, and Roche have all launched new R&D facilities in Shanghai. There are, however, significant concerns about the protection of intellectual property rights. There are also concerns regarding whether the testing and manufacturing of pharmaceutical products conducted in China will be in compliance with the U.S regulations. This chapter includes a discussion about how the FDA approves pharmaceutical products to be marketed in the U.S. We discuss the FDA requirements applicable to non-clinical testing, including addressing the Good Laboratory Practice for Nonclinical Laboratory, requirements applicable to clinical testing, with regard to clinical studies under an investigational new drug application, and FDA requirements applicable to manufacturing of pharmaceutical products, including regulations relevant to the manufacturing of active ingredients. Wealso discuss considerations for non-Chinese companies working with Chinese partners to assure compliance with these FDA requirements.

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Eric Langer
BioPlan Associates, Inc.
2275 Research Blvd, Suite 500
Rockville, MD 20850
Phone: 301-921-5979; Fax: 301-926-2455