BRIEF—Novotech outlines route to China biotech research

25 October 2022

Asia-Pacific-focused contract research organization (CRO) Novotech has commissioned a report for biotechs considering China for their clinical research.

The document provides some detail on the relevant processes required for US Food and Drug Administration approvals.

The research found that China's clinical development regulations “are aligned with the US FDA regulations and present significant benefits for biopharma companies.”

In addition, biotech firms “should take advantage of China's revised regulatory framework around acceptance of foreign clinical trials data for drug approval,” Novotech said.

Clinical services head Yooni Kim said: "China presents exceptional clinical opportunities with a vast population and world class research facilities and key opinion leaders.”