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Balancing Societal Needs and Regulatory Certainty: The Case Study of Peramivir in Japan
Author(s) -
Tominaga T,
Ando Y,
Nagai N,
Sato J,
Kondo T
Publication year - 2013
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2012.268
Subject(s) - certainty , business , medicine , mathematics , geometry
Regulators must balance societal and medical requirements against the need for certainty about benefit and risk for new medicines. This is described in a case study of the expedited review and approval of peramivir, a novel neuraminidase inhibitor, in Japan in the context of the emergence of new strain of influenza in 2009. The case illustrates the importance of regulatory science and transparency in supporting such decision making. Clinical Pharmacology & Therapeutics (2013); 93 4, 342–344. doi: 10.1038/clpt.2012.268