Global harmonisation blueprint sheds prescriptive feel
This article was originally published in Clinica
Proposals unveiled this month for the modus operandi of the Global Harmonisation Task Force (GHTF) should ensure that companies are given equal footing with regulators in its decision-making process. An ad hoc working group of senior regulators and industry representatives is close to finalising the GHTF's first written operating instructions. Its suggestions succeed in removing much of the prescriptive character proposed for the body 18 months ago by the US FDA.