CFDA reforms drug classification system

China FDA will no longer classify drugs marketed elsewhere in the world as new drugs, according Sidley Austin LLP. The agency previously categorized all therapeutics not yet marketed in China as new drugs, even if they were marketed elsewhere (see BioCentury Extra, Aug. 19, 2015).

The change is part of a new classification system that may give multinational companies incentives to begin clinical development in China at earlier stages, the firm said. Sidley specializes in Asia-Pacific life sciences law. ...