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Drug Development and Industrial Pharmacy Volume 4, 1978 - Issue 1
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Research Article

Worldwide Regulations and Legislation; Their Effects on Pharmaceutical Product Development

Bernard A. Haines Technical Director International Regulatory Affairs E. R. Squibb & Sons, Inc. Princeton, New Jersey, 08540
Pages 1-30 | Published online: 20 Oct 2008
 
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Abstract

The pharmaceutical industry has become one of the most legislated and regulated industries in the world. The worldwide regulations although differing in scope and intensity all target on the pharmaceutical development, testing and manufacture of drug products. The impact of the constantly changing worldwide legislation and regulations is a primary concern.

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