Document Detail


Internationalization of regulatory requirements.
MedLine Citation:
PMID:  12588627     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The aim of harmonisation of medicines regulatory requirements is to allow the patient quicker access to new drugs and to avoid animal and human duplications. Harmonisation in the European Union (EU) is now completed, and has led to the submission of one dossier in one language study leading to European marketing authorizations, thanks in particular to efficacy guidelines published at the European level. With the benefit of the European experience since 1989, more than 40 guidelines have been harmonised amongst the EU, Japan and the USA through the International Conference on Harmonisation (ICH). ICH is a unique process gathering regulators and industry experts from the three regions. Its activity is built on expertise and trust. The Common Technical Document (CTD), an agreed common format for application in the three regions, is a logical follow-up to the ICH first phase harmonising the content of the dossier. The CTD final implementation in July 2003 will have considerable influence on the review process and on the exchange of information in the three regions.
Authors:
Y Juillet
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Fundamental & clinical pharmacology     Volume:  17     ISSN:  0767-3981     ISO Abbreviation:  Fundam Clin Pharmacol     Publication Date:  2003 Feb 
Date Detail:
Created Date:  2003-02-17     Completed Date:  2003-10-03     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8710411     Medline TA:  Fundam Clin Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  21-5     Citation Subset:  IM    
Affiliation:
Syndicat National de L'Industrie Pharmaceutique, Paris, France. yjuillet@snip.fr
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MeSH Terms
Descriptor/Qualifier:
Drug Industry / legislation & jurisprudence*,  standards
European Union
Guidelines as Topic
Humans
International Cooperation*
Pharmaceutical Preparations / standards
Quality Control
Chemical
Reg. No./Substance:
0/Pharmaceutical Preparations

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


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