Regulation of biotechnology products in the global pharmaceutical market: the case of the European community and the United States.
Biotechnology represents an opportunity for innovative products, new markets, or capital investments, depending on one's perspective. A primary consideration in regulating this industry is to ensure that innovation is not stifled yet the public is protected from potentially unsafe or ineffective products. We compared the regulatory requirements and procedures for obtaining marketing approval for biotechnology products in the European Community (EC) and the United States and identified key concerns of the biotechnology industry regarding the regulatory aspects of these products. The methodology consisted of a secondary literature review and mail survey. Biotechnology products are approved faster in the EC than the US. Both the EC and the US use advisory or expert committees in their respective approval procedures, although the EC does so more regularly. Market exclusivity provisions for biotechnology products range from 6 to 10 years in the EC compared with 7 years for "orphan" biotechnology products in the US. Regulatory affairs managers of the biotechnology industry were most concerned about application review time periods, communication with regulatory agencies, consistency in implementing regulations, and public policy changes. These concerns provide insight into the deficiencies that exist in regulatory processes and are valuable in identifying problems and implementing improvements.
Hakim
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Z
Division of Pharmaceutical Administration, Ohio State University, Columbus.
Kucukarslan
S
S
D001709:Biotechnology / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005062:European Union; D014481:United States