Date: 10-Aug-2019

Sandoz receives regulatory approval from NMPA for Rosuvastatin

Sandoz has announced that it has received regulatory approval from Chinas National Medical Products Administration (NMPA) for its generic Rosuvastatin, under the NMPAs Quality Consistency Evaluation (QCE) system. Sandoz is the first multinational pharmaceutical company to receive such an approval under the recently introduced QCE system, which aims to ensure that all generic medicines marketed (or manufactured) in China meet internationally recognized quality standards. The QCE regulations are part of a wide-ranging package of healthcare system reforms introduced by the Chinese government over the past few years, which also offer the potential to accelerate national generic registration timelines significantly.