In an effort to streamline its drug approval process, the Chinese government will expedite the review of 48 urgently needed drugs already approved outside of China. Under these eased requirements announced in August, the China National Drug Administration (CNDA) will waive the mandate that requires clinical trials of the drugs to be conducted locally in China. To qualify for the speedy clearance, manufacturers of the critically needed drugs will need to show that their products have already been approved by health authorities in Japan, the United States, or Europe. They also need to submit data to demonstrate that no racial or ethnic differences between the populations will affect the product’s efficacy.
The drugs impacted by the new regulatory action are designed to treat or prevent rare and life-threatening diseases. They have been deemed as clinically urgent by Chinese authorities.