First-of-its-kind approval for Sandoz in China for generic statin

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/Rainer Puster)
(Image: Getty/Rainer Puster)

Related tags: China, Regulations, Generic drug, Generics, Statin, Sandoz

Sandoz receives approval of its generic statin in China and states it will continue to grow its generic portfolio in the country.

China’s National Medical Products Administration (NMPA) approves Sandoz’ generic rosuvastatin, which is marketed by AstraZeneca under the name Crestor. With this, Sandoz becomes the first multinational company to receive approval under the recently introduced QCE system.

China’s NMPA quality consistency evaluation system (QCE) was recently introduced to ensure that all generic medicines that are either marketed or manufactured in China meet international quality standards.

The QCE regulations are part of a package of health care system reforms the Chinese government introduced in recent years to accelerate national generic registration timelines.

After this first of its kind generic approval for a multinational company, Sandoz stated it will continue to submit generic applications in China, focusing on areas of unmet need to expand access to its global portfolio of generics and biosimilars.

Francesco Balestrieri, interim CEO of Sandoz, said in a statement, “This regulatory milestone helps to pave the way for Sandoz to compete in future generic tenders in China, as the evolving tender system increasingly moves to favor QCE-approved molecules.”

Rosuvastatin, a therapy in the drug group known as statins, is indicated for the reduction of heart disease risk and prevention of stroke and heart attack.

Related topics: Regulatory & Safety, Regulations

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