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GHTF (Global Harmonisation Task Force) & MRAs (Mutual Recognition Agreements) - the highs and lows of global regulatory efforts

This article was originally published in Clinica

Executive Summary

Much has been achieved towards encouraging bilateral and even global acceptance of different regulatory approaches as well as towards converging standards requirements in key areas. Indeed, regulatory compliance is becoming easier for international manufacturers and future business is looking good for certification bodies offering one-stop testing. But 2003 was not an easy year for the regulators, as Amanda Maxwell reports

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