China drops clinical trial mandate for 30 urgently needed drugs

Seeking to encourage pharmaceutical companies to market urgently needed new drugs already approved in the United States, China’s National Medical Products Administration (NMPA) is waiving the requirement for clinical trials on 30 such therapies.

The list published by the NMPA on March 28 adds 14 orphan disease therapies, antibiotics, and other pharmaceutical products to the 48 drugs already made eligible in August 2018 for what the NMPA calls “super fast-track” status. The new drugs added include orphan drugs. They also include treatments for life-threatening diseases for which there is either currently no approved product, or for which the new drug offers a substantial clinical advantage over existing approved therapies.

The drugs on the newly published list include therapies for HIV/AIDS, hepatitis, pulmonary hypertension, hemophilia, Crohn’s disease, multiple sclerosis, Fabry disease, and prostate cancer.