Signs are emerging that China will tighten its policies governing clinical trials of drugs produced in the country, part of a series of moves to bolster the study of the safety and effectiveness of pharmaceuticals and to bring them fully in line with international standards.
Several high-ranking officials have spoken out in recent months on the need to strengthen existing regulations, even as an initial move to require higher standards for oncology drug clinical studies in China has engendered a downturn in many Chinese biotech stocks.
Standards on drug safety and effectiveness are set by the International Council of Technical Requirements for Pharmaceuticals for Human Use (ICH). But China, which until recently has lagged behind its Western competitors on clinical research and approvals of new drugs, has not always demanded adherence with ICH requirements. Unlike international firms, which conduct multiple trials of drugs, Chinese firms often conduct only one Phase III trial before filing new drug applications.