Document Detail

A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.
MedLine Citation:
PMID:  23362829     Owner:  NLM     Status:  MEDLINE    
We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to six (38%) and CHMP granted (the equivalent) conditional approvals to four (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared with 409.6 days in the European Union (EU). The active review times, however, were comparable (225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20 days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations.
Rashmi R Shah; Samantha A Roberts; Devron R Shah
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Publication Detail:
Type:  Comparative Study; Journal Article; Review    
Journal Detail:
Title:  British journal of clinical pharmacology     Volume:  76     ISSN:  1365-2125     ISO Abbreviation:  Br J Clin Pharmacol     Publication Date:  2013 Sep 
Date Detail:
Created Date:  2013-09-16     Completed Date:  2014-05-02     Revised Date:  2014-09-02    
Medline Journal Info:
Nlm Unique ID:  7503323     Medline TA:  Br J Clin Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  396-411     Citation Subset:  IM    
Copyright Information:
© 2013 The Authors. British Journal of Clinical Pharmacology © 2013 The British Pharmacological Society.
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MeSH Terms
Antineoplastic Agents* / administration & dosage,  adverse effects,  therapeutic use
Drug Approval / legislation & jurisprudence,  methods*
European Union
Government Agencies*
Neoplasms / drug therapy,  enzymology
Protein Kinase Inhibitors* / administration & dosage,  adverse effects,  therapeutic use
Protein-Tyrosine Kinases / antagonists & inhibitors*
Time Factors
United States
United States Food and Drug Administration*
Reg. No./Substance:
0/Antineoplastic Agents; 0/Protein Kinase Inhibitors; EC Kinases

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

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