China’s New Drug Regs Overlook Key Issues of Concern to Multinationals
This article was originally published in PharmAsia News
Executive Summary
While China made progress overhauling the drug and device regulations this year, multinationals are worried about a few things the government has yet to tackle: defining what constitutes a "new chemical entity," assuring the confidentiality of data submitted for drug registration, and linking drug approvals to patent protection