Sandoz’s rosuvastatin approved under China’s new Quality Consistency Evaluation system

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Sandoz’s rosuvastatin approved under China’s new Quality Consistency Evaluation system

Biosimilares/Novedades | Posted 14/06/2019 0 Post your comment

Sandoz, the generics division of Novartis, announced on 9 May 2019 that it had received regulatory approval from China's National Medical Products Administration (NMPA) for its generic rosuvastatin, under the recently introduced Quality Consistency Evaluation (QCE) system.

Sandoz is the first multinational pharmaceutical company to receive approval for a generic drug under the QCE system. The QCE system is an extensive set of health system reforms introduced by the government in China over the last few years which aim to ensure that all generic medicines marketed or manufactured in China meet internationally recognized quality standards. The reforms also offer the potential to significantly reduce the timeframe for registration of generic medicines in China.

Sandoz plans to submit further generics applications in China, focussing specifically on areas of greatest unmet need.

According to Francesco Balestrieri, ad interim CEO at Sandoz: ‘This first-of-a-kind generic approval for a multinational company demonstrates our strategic focus on pioneering access to high quality medicines in China, which is the world's largest generics market and offers enormous future potential to address unmet needs, particularly in the area of chronic diseases’.

Mr Balestrieri added: ‘Specifically, this regulatory milestone helps to pave the way for Sandoz to compete in future generic drug tenders in China, as the evolving tender system increasingly moves to favour QCE-approved molecules. We see great potential to grow long-term in China and have the commitment and capabilities to succeed, including programs to conduct R & D and clinical development in China, specifically for the Chinese market’.

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