Document Detail


The effect of globalization of drug manufacturing, production, and sourcing and challenges for American drug safety.
MedLine Citation:
PMID:  18253142     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Americans benefit from one of the safest drug supplies and one of the highest standards of consumer protection in the world. Over the past decade, though, a general trend toward globalization of the supply chains for finished pharmaceutical products and active pharmaceutical ingredients has created new challenges for the Food and Drug Administration (FDA) in ensuring the safety and quality of the drug supply. Explosive growth in pharmaceutical manufacturing for the US market is particularly evident in the developing regions of Asia. Manufacturing sites in China and India now comprise approximately 40% of all FDA-registered foreign sites, having increased from 30% in 2002. (In 2001, when legislation first went into effect requiring registration of all foreign drug manufacturing sites, 140 registered sites in China listed 797 drug items for potential importation; as of 1 October 2007, that number had grown to 815 registered sites and well over 3,000 listed items.) In total in 2006, the United States received >145,000 line entries of imported drug products from >160 countries, up from only 1,300 line entries in 2000. FDA regulatory oversight resources (e.g., those allocated to inspection and testing of imports) are being challenged to keep up with the explosive growth of imported drugs. (In 2006, the FDA performed inspections at 212 foreign drug firms. This number has remained relatively consistent over the past 6 years, starting at 249 in 2001 and ranging from 190 to 260 on an annual basis.)
Authors:
J Woo; S Wolfgang; H Batista
Publication Detail:
Type:  Journal Article; Review     Date:  2008-02-06
Journal Detail:
Title:  Clinical pharmacology and therapeutics     Volume:  83     ISSN:  1532-6535     ISO Abbreviation:  Clin. Pharmacol. Ther.     Publication Date:  2008 Mar 
Date Detail:
Created Date:  2008-02-20     Completed Date:  2008-03-13     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372741     Medline TA:  Clin Pharmacol Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  494-7     Citation Subset:  AIM; IM    
Affiliation:
Office of Compliance, Food and Drug Administration/Center for Drug Evaluation and Research, Rockville, Maryland, USA. jason.woo@fda.hhs.gov
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MeSH Terms
Descriptor/Qualifier:
Drug Design*
Drug Industry / standards*,  trends*
Humans
International Cooperation
Outsourced Services / standards,  trends*
Pharmaceutical Preparations / adverse effects*,  chemical synthesis,  standards*
United States
United States Food and Drug Administration / standards,  trends
Chemical
Reg. No./Substance:
0/Pharmaceutical Preparations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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