ICH: An exclusive club of drug regulatory agencies and drug companies imposing its rules on the rest of the world

摘要

? Under the pretext of harmonising regulatory requirements for marketing authorisation of new drugs, the drug regulatory agencies of the world's wealthiest countries and three pharmaceutical industry trade associations, joined together since 1990 in the ICH, are promoting their own interests by imposing their criteria for evaluating drugs on the whole world. ? The toxicity standards advocated by ICH sometimes promote faster, cheaper drug development over patient protection. ? The drug quality standards advocated by ICH sometimes increase manufacturing costs without providing any public health benefit. ? It would be preferable if the World Health Organization were in charge of setting standards for drug development, focusing on patients' interests.