U.S.-China clear some air on clinical pathways

China has explicitly made clear that pharma companies can obtain waivers to avoid running domestic clinical trials after conducting multiregional clinical trials (MRCTs) that meet the government's technical requirements for use of Chinese data.

The disclosure, made at the annual U.S.-China Joint Commission on Commerce and Trade (JCCT) in Chicago earlier this month, did not resolve uncertainty about how long a sponsor may wait in line at China FDA to apply for the waiver, but discussions appear to be moving in a positive direction, according to attorneys in China. ...