BioCentury
ARTICLE | Strategy

Opening the gates in China

HCV competition in China shows how regulatory changes have leveled the field

December 2, 2017 1:27 AM UTC

A flurry of approvals of HCV drugs in China this year illustrates how the country’s regulatory reforms have leveled the playing field for multinational drug sponsors, who had been disadvantaged compared with domestic companies.

As part of the government’s decade-long campaign to catalyze development of innovative pharmaceuticals by domestic companies, CFDA had adopted policies intended to speed their review. At the same time, it erected hurdles that only foreign companies had to clear, potentially delaying approval of their products by years...