PMID: 12765701May 27, 2003Paper

Reshaping the carcinogenic risk assessment of medicines: international harmonisation for drug safety, industry/regulator efficiency or both?

Social Science & Medicine
John Abraham, Tim Reed

Abstract

The most significant institutional entity involved in the harmonisation of drug testing standards worldwide is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which comprises the three pharmaceutical industry associations and regulatory agencies of the EU, US and Japan. It is often claimed that such harmonisation will both accelerate the development and approval of new drugs and preserve safety standards, if not strengthen safety regimes. Drawing on extensive documentary research and interviews, this paper systematically examines whether the efforts by the ICH to improve industrial and regulatory efficiency by harmonising drug testing requirements is likely to raise, maintain or compromise safety standards in carcinogenic risk assessment of pharmaceuticals. The evidence suggests that, in the field of carcinogenicity testing, the ICH management of international harmonisation of medicines regulation is not achieving simultaneous improvements in safety standards and acceleration of drug development. Rather, the latter is being achieved at the expense of the former. Indeed, the ICH may be converting permissive regulatory practices of the past into new ...Continue Reading

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Citations

Sep 3, 2008·Sociology of Health & Illness·Simon J WilliamsPeter Davis
Apr 30, 2013·Social Science & Medicine·Ayo WahlbergNikolas Rose
Jan 19, 2011·Expert Opinion on Pharmacotherapy·Francesco TecilazichAristidis Veves
Nov 25, 2005·Social Studies of Science·Philip Mirowski, Robert Van Horn
Nov 25, 2004·International Journal of Health Services : Planning, Administration, Evaluation·Karin Timmermans
Jan 30, 2013·Philosophical Transactions. Series A, Mathematical, Physical, and Engineering Sciences·Robert U Ayres, Laura Talens Peiró
Aug 24, 2018·Globalization and Health·Mary WiktorowiczJoel Lexchin
May 11, 2020·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Morteza Najaf Zadeh GharaboghazShahram Saghaie

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