Generics group wants say in international drug standards

The International Generic Pharmaceutical Alliance says the International Conference on Harmonization won't allow representation from makers of generic drugs on a panel in charge of decisions on drug manufacturing, efficacy, safety and clinical studies. "[The] generic industry will remain completely barred from the formal ICH decision-making process, even though the vast majority of ICH guidelines become regulatory requirements and guidances that are directly applicable to generic pharmaceutical manufacturers," the group said in a letter to ICH.

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